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CompletedNCT03187418Updated Oct 8, 2021Results posted

Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma

An interventional study of MicroPulse® P3 Glaucoma Device (MP3) in Glaucoma, Glaucoma, Open-Angle and Glaucoma, Neovascular, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-08.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this study is to evaluate the efficacy and safety of the novel form of trans-scleral cyclophotocoagulation using micropulse diode laser and trans-pars plana treatment (Micropulse TSCPC, mTSCPC MP3, IRIDEX CYCLO G6™ Glaucoma Laser System, CA, USA) in adults for the treatment of uncontrolled glaucoma.

Read the detailed description

Cyclophotocoagulation (CPC) is a type of cycloablation using laser to treat glaucoma. It involves ciliary body destruction by targeting the ciliary epithelium and stroma, resulting in a reduction in aqueous secretion and hence intraocular pressure. This strategy is effective for all forms of glaucoma.

Traditional trans-scleral cyclophotocoagulation (TSCPC) achieve its cyclodestructive action by using continuous diode laser to target the melanin in the pigmented ciliary body epithelium. However, the continuous mode has been shown to cause significant collateral tissue damage to adjacent non-pigmented structures including the ciliary stroma and ciliary muscle. Traditional TSCPC may therefore be associated with serious complications including uveitis, visual deterioration, chronic hypotony, and others.

More recently, a micropulse delivery mode of diode laser (Micropulse TSCPC, mTSCPC) has been used to treat glaucoma by ablating the ciliary processes and reduce aqueous humor production with more selective targeting and less collateral damage. In contrast to conventional laser delivery where a continuous flow of high intensity energy is delivered, micropulse laser application delivers a series of repetitive short pulses of energy with rest periods in between pulses. Only a few studies have described the outcomes of this novel glaucoma therapy, showing mTSCPC to have comparable efficacy with fewer side effects when compared with traditional continuous wave mode diode laser delivery.This improved side effect profile has the potential to make mTSCPC an earlier therapeutic option instead of reserving it exclusively for end-stage refractory eyes.

02

Conditions studied

  • Glaucoma
  • Glaucoma, Open-Angle
  • Glaucoma, Neovascular
  • Glaucoma and Ocular Hypertension
  • Glaucoma Eye
  • Glaucoma, Uncompensated
  • Glaucoma Secondary

Keywords

  • Cyclophotocoagulation
  • Micropulse TSCPC
  • Laser ablation
  • Laser therapy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients of either sex and any race aged 18 years old and above.
  • Followed by a glaucoma subspecialist at University of Montreal Hospital Center.

  • Intraocular pressure (IOP) above target and unresponsive to maximal tolerated medical therapy with or without previous surgical intervention.

    1. mild glaucoma: IOP > 18 mmHg
    2. moderate glaucoma: IOP > 15 mmHg
    3. advanced glaucoma: IOP > 12 mmHg
  • Considered poor candidates for additional filtering surgery or implantation of glaucoma drainage devices.

Exclusion criteria

Exclusion Criteria:

  • Patients unable to give informed consent.
  • Patients with significant scleral thinning, defined as thinning of more than one clock hour noticed on scleral transillumination.
  • Ocular infection or inflammation in the study eye in the 2 months prior to enrolment.
  • Intraocular surgery in the study eye in the 2 months prior to enrolment.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Micropulse trans-scleral CPC

    A treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA).

    Device: MicroPulse® P3 Glaucoma Device (MP3)

Interventions

  • DeviceMicroPulse® P3 Glaucoma Device (MP3)

    Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).

    Also known as: CYCLO G6 Glaucoma Laser System (Iridex, Mountain View, CA)

05

What researchers measure

Primary outcomes

  1. Intraocular Pressure (IOP)

    In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

    Time frame: 18 months

Secondary outcomes

  1. Intraocular Pressure (IOP)

    In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

    Time frame: 1 week, 1 month, 3 months, 6 months, 12 months

  2. Number of Participants With Repeat Treatments

    Number of participants needing a repeat laser treatment during the study

    Time frame: 18 months

  3. Number of Intraocular Pressure Lowering Medications

    Number of drops and oral medications used by the patient compared to baseline

    Time frame: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months

  4. Corrected Distance Visual Acuity (CDVA)

    Number of lines reduction or improvement from baseline on Snellen acuity chart at 6 meters

    Time frame: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months

  5. Cup-to-disc Ratio (CDR)

    Progression of CDR compared to baseline, assessed by an ophthalmologist on dilated fundus examination

    Time frame: 18 months

  6. Visual Field Index (VFI)

    Determined by Humphrey automated perimetry Sita 24-2 visual field testing

    Time frame: 18 months

  7. Mean Deviation (MD)

    Determined by Humphrey automated perimetry Sita 24-2 visual field testing

    Time frame: 18 months

  8. Pattern Standard Deviation (PSD)

    Determined by Humphrey automated perimetry Sita 24-2 visual field testing

    Time frame: 18 months

  9. Average Retinal Nerve Fiber Layer (RNFL) Thickness

    In micrometer, determined by optical coherence tomography (OCT)

    Time frame: 18 months

  10. Average Ganglion Cell Layer (GCL) Thickness

    In micrometer, determined by optical coherence tomography (OCT)

    Time frame: 18 months

  11. Cup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT)

    Progression of vertical CDR compared to baseline, assessed by optical coherence tomography (OCT) parameters

    Time frame: 18 months

  12. Pain Level During Laser Treatment

    Using a verbal analog scale for pain level (none = no subjective feeling of pain, mild = pain easily tolerable, moderate = pain tolerable with difficulty, severe = pain intolerable)

    Time frame: 1 day

06

Results

Posted Oct 8, 2021

Participant flow

Participant flow — Overall Study
MilestoneMicropulse Trans-scleral CPC
Started52
Completed52
Not completed0

Outcome measures

PrimaryIntraocular Pressure (IOP)

In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

Time frame:
18 months
Reported as:
Mean · millimeters of mercury (mm Hg)
Intraocular Pressure (IOP)
millimeters of mercury (mm Hg)Micropulse Trans-scleral CPC
Intraocular Pressure (IOP)15.2 ± 4.1
SecondaryIntraocular Pressure (IOP)

In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

Time frame:
1 week, 1 month, 3 months, 6 months, 12 months
Reported as:
Mean · millimeters of mercury (mm Hg)
Intraocular Pressure (IOP)
millimeters of mercury (mm Hg)Micropulse Trans-scleral CPC
1 week18.2 ± 6.3
1 month19.2 ± 7.4
3 months18.6 ± 6.2
6 months17.9 ± 5.3
12 months16.7 ± 5.6
SecondaryNumber of Participants With Repeat Treatments

Number of participants needing a repeat laser treatment during the study

Time frame:
18 months
Reported as:
Count of participants · Participants
Number of Participants With Repeat Treatments
ParticipantsMicropulse Trans-scleral CPC
Number of Participants With Repeat Treatments10
SecondaryNumber of Intraocular Pressure Lowering Medications

Number of drops and oral medications used by the patient compared to baseline

Time frame:
1 week, 1 month, 3 months, 6 months, 12 months, 18 months
Reported as:
Mean · glaucoma medication classes
Number of Intraocular Pressure Lowering Medications
glaucoma medication classesMicropulse Trans-scleral CPC
1 week3.5 ± 0.7
1 month3.4 ± 0.8
3 months3.4 ± 0.9
6 months3.4 ± 0.8
12 months3.2 ± 0.9
18 months3.2 ± 0.9
SecondaryCorrected Distance Visual Acuity (CDVA)

Number of lines reduction or improvement from baseline on Snellen acuity chart at 6 meters

Time frame:
1 week, 1 month, 3 months, 6 months, 12 months, 18 months
Reported as:
Mean · LogMAR
Corrected Distance Visual Acuity (CDVA)
LogMARMicropulse Trans-scleral CPC
1 week0.81 ± 0.86
1 month0.84 ± 0.90
3 months0.79 ± 0.88
6 months0.77 ± 0.86
12 months0.79 ± 0.86
18 months0.82 ± 0.88
SecondaryCup-to-disc Ratio (CDR)

Progression of CDR compared to baseline, assessed by an ophthalmologist on dilated fundus examination

Time frame:
18 months
Reported as:
Mean · ratio
Cup-to-disc Ratio (CDR)
ratioMicropulse Trans-scleral CPC
Cup-to-disc Ratio (CDR)0.82 ± 0.13
SecondaryVisual Field Index (VFI)

Determined by Humphrey automated perimetry Sita 24-2 visual field testing

Time frame:
18 months
Reported as:
Mean · percents
Visual Field Index (VFI)
percentsMicropulse Trans-scleral CPC
Visual Field Index (VFI)57 ± 27
SecondaryMean Deviation (MD)

Determined by Humphrey automated perimetry Sita 24-2 visual field testing

Time frame:
18 months
Reported as:
Mean · decibel (dB)
Mean Deviation (MD)
decibel (dB)Micropulse Trans-scleral CPC
Mean Deviation (MD)-15.16 ± 7.72
SecondaryPattern Standard Deviation (PSD)

Determined by Humphrey automated perimetry Sita 24-2 visual field testing

Time frame:
18 months
Reported as:
Mean · decibel (dB)
Pattern Standard Deviation (PSD)
decibel (dB)Micropulse Trans-scleral CPC
Pattern Standard Deviation (PSD)7.87 ± 3.18
SecondaryAverage Retinal Nerve Fiber Layer (RNFL) Thickness

In micrometer, determined by optical coherence tomography (OCT)

Time frame:
18 months
Reported as:
Mean · micrometers
Average Retinal Nerve Fiber Layer (RNFL) Thickness
micrometersMicropulse Trans-scleral CPC
Average Retinal Nerve Fiber Layer (RNFL) Thickness62 ± 12
SecondaryAverage Ganglion Cell Layer (GCL) Thickness

In micrometer, determined by optical coherence tomography (OCT)

Time frame:
18 months
Reported as:
Mean · micrometers
Average Ganglion Cell Layer (GCL) Thickness
micrometersMicropulse Trans-scleral CPC
Average Ganglion Cell Layer (GCL) Thickness53 ± 14
SecondaryCup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT)

Progression of vertical CDR compared to baseline, assessed by optical coherence tomography (OCT) parameters

Time frame:
18 months
Reported as:
Mean · ratio
Cup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT)
ratioMicropulse Trans-scleral CPC
Cup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT)0.82 ± 0.13
SecondaryPain Level During Laser Treatment

Using a verbal analog scale for pain level (none = no subjective feeling of pain, mild = pain easily tolerable, moderate = pain tolerable with difficulty, severe = pain intolerable)

Time frame:
1 day
Reported as:
Count of participants · Participants
Pain Level During Laser Treatment
ParticipantsMicropulse Trans-scleral CPC
None34
Mild12
Moderate6
Severe0

Adverse events

Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Micropulse Trans-scleral CPC0/52 (0%)0/52 (0%)0/52 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Micropulse Trans-scleral CPC
Mean69 ± 14
Sex: Female, Male
Sex: Female, Male(Participants)Micropulse Trans-scleral CPC
Female26
Male26
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Micropulse Trans-scleral CPC
Caucasian41
African American6
Middle East3
Asian2
Region of Enrollment
Region of Enrollment(participants)Micropulse Trans-scleral CPC
Canada52
Glaucoma diagnosis
Glaucoma diagnosis(Participants)Micropulse Trans-scleral CPC
Primary open angle glaucoma28
Neovascular glaucoma5
Pseudoexfoliative glaucoma4
Congenital/infantile glaucoma4
Chronic primary angle-closure glaucoma3
Pigmentary glaucoma3
Other secondary glaucoma2
Uveitic/inflammatory glaucoma1
Combined mechanism glaucoma1
Normotensive glaucoma1
Glaucoma severity
Glaucoma severity(Participants)Micropulse Trans-scleral CPC
Mild1
Moderate16
Advanced35
07

Study locations

1 site
  • Centre Hospitalier de l'Université de Montréal (CHUM)
    Montréal, Quebec H2X 3E4, Canada
08

References and documents

Publications

  • Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224. PubMed 16488940 ↗
  • Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26. PubMed 24974815 ↗
  • Nguyen QH. Primary surgical management refractory glaucoma: tubes as initial surgery. Curr Opin Ophthalmol. 2009 Mar;20(2):122-5. doi: 10.1097/ICU.0b013e32831da828. PubMed 19240544 ↗
  • Schlote T, Derse M, Rassmann K, Nicaeus T, Dietz K, Thiel HJ. Efficacy and safety of contact transscleral diode laser cyclophotocoagulation for advanced glaucoma. J Glaucoma. 2001 Aug;10(4):294-301. doi: 10.1097/00061198-200108000-00009. PubMed 11558814 ↗
  • Agarwal HC, Gupta V, Sihota R. Evaluation of contact versus non-contact diode laser cyclophotocoagulation for refractory glaucomas using similar energy settings. Clin Exp Ophthalmol. 2004 Feb;32(1):33-8. doi: 10.1046/j.1442-9071.2004.00754.x. PubMed 14746588 ↗
  • Schlote T, Derse M, Zierhut M. Transscleral diode laser cyclophotocoagulation for the treatment of refractory glaucoma secondary to inflammatory eye diseases. Br J Ophthalmol. 2000 Sep;84(9):999-1003. doi: 10.1136/bjo.84.9.999. PubMed 10966953 ↗
  • Egbert PR, Fiadoyor S, Budenz DL, Dadzie P, Byrd S. Diode laser transscleral cyclophotocoagulation as a primary surgical treatment for primary open-angle glaucoma. Arch Ophthalmol. 2001 Mar;119(3):345-50. doi: 10.1001/archopht.119.3.345. PubMed 11231767 ↗
  • Leszczynski R, Gierek-Lapinska A, Forminska - Kapuscik M. Transscleral cyclophotocoagulation in the treatment of secondary glaucoma. Med Sci Monit. 2004 Sep;10(9):CR542-8. Epub 2004 Aug 20. PubMed 15328489 ↗
  • Rotchford AP, Jayasawal R, Madhusudhan S, Ho S, King AJ, Vernon SA. Transscleral diode laser cycloablation in patients with good vision. Br J Ophthalmol. 2010 Sep;94(9):1180-3. doi: 10.1136/bjo.2008.145565. Epub 2010 Jun 24. PubMed 20576775 ↗
  • Pantcheva MB, Kahook MY, Schuman JS, Rubin MW, Noecker RJ. Comparison of acute structural and histopathological changes of the porcine ciliary processes after endoscopic cyclophotocoagulation and transscleral cyclophotocoagulation. Clin Exp Ophthalmol. 2007 Apr;35(3):270-4. doi: 10.1111/j.1442-9071.2006.01415.x. PubMed 17430515 ↗
  • Tan AM, Chockalingam M, Aquino MC, Lim ZI, See JL, Chew PT. Micropulse transscleral diode laser cyclophotocoagulation in the treatment of refractory glaucoma. Clin Exp Ophthalmol. 2010 Apr;38(3):266-72. doi: 10.1111/j.1442-9071.2010.02238.x. PubMed 20447122 ↗
  • Aquino MC, Barton K, Tan AM, Sng C, Li X, Loon SC, Chew PT. Micropulse versus continuous wave transscleral diode cyclophotocoagulation in refractory glaucoma: a randomized exploratory study. Clin Exp Ophthalmol. 2015 Jan-Feb;43(1):40-6. doi: 10.1111/ceo.12360. Epub 2014 Jun 21. PubMed 24811050 ↗
  • Bloom PA, Tsai JC, Sharma K, Miller MH, Rice NS, Hitchings RA, Khaw PT. "Cyclodiode". Trans-scleral diode laser cyclophotocoagulation in the treatment of advanced refractory glaucoma. Ophthalmology. 1997 Sep;104(9):1508-19; discussion 1519-20. doi: 10.1016/s0161-6420(97)30109-2. PubMed 9307649 ↗
  • Kosoko O, Gaasterland DE, Pollack IP, Enger CL. Long-term outcome of initial ciliary ablation with contact diode laser transscleral cyclophotocoagulation for severe glaucoma. The Diode Laser Ciliary Ablation Study Group. Ophthalmology. 1996 Aug;103(8):1294-302. doi: 10.1016/s0161-6420(96)30508-3. PubMed 8764801 ↗
  • Mistlberger A, Liebmann JM, Tschiderer H, Ritch R, Ruckhofer J, Grabner G. Diode laser transscleral cyclophotocoagulation for refractory glaucoma. J Glaucoma. 2001 Aug;10(4):288-93. doi: 10.1097/00061198-200108000-00008. PubMed 11558813 ↗
  • Oguri A, Takahashi E, Tomita G, Yamamoto T, Jikihara S, Kitazawa Y. Transscleral cyclophotocoagulation with the diode laser for neovascular glaucoma. Ophthalmic Surg Lasers. 1998 Sep;29(9):722-7. PubMed 9760607 ↗
  • Sivaprasad S, Sandhu R, Tandon A, Sayed-Ahmed K, McHugh DA. Subthreshold micropulse diode laser photocoagulation for clinically significant diabetic macular oedema: a three-year follow up. Clin Exp Ophthalmol. 2007 Sep-Oct;35(7):640-4. doi: 10.1111/j.1442-9071.2007.01566.x. PubMed 17894684 ↗
  • Parodi MB, Spasse S, Iacono P, Di Stefano G, Canziani T, Ravalico G. Subthreshold grid laser treatment of macular edema secondary to branch retinal vein occlusion with micropulse infrared (810 nanometer) diode laser. Ophthalmology. 2006 Dec;113(12):2237-42. doi: 10.1016/j.ophtha.2006.05.056. Epub 2006 Sep 25. PubMed 16996596 ↗
  • Desmettre TJ, Mordon SR, Buzawa DM, Mainster MA. Micropulse and continuous wave diode retinal photocoagulation: visible and subvisible lesion parameters. Br J Ophthalmol. 2006 Jun;90(6):709-12. doi: 10.1136/bjo.2005.086942. Epub 2006 Mar 10. PubMed 16531424 ↗
  • Laursen ML, Moeller F, Sander B, Sjoelie AK. Subthreshold micropulse diode laser treatment in diabetic macular oedema. Br J Ophthalmol. 2004 Sep;88(9):1173-9. doi: 10.1136/bjo.2003.040949. PubMed 15317711 ↗
  • Moorman CM, Hamilton AM. Clinical applications of the MicroPulse diode laser. Eye (Lond). 1999 Apr;13 ( Pt 2):145-50. doi: 10.1038/eye.1999.41. PubMed 10450372 ↗
  • Pollack JS, Kim JE, Pulido JS, Burke JM. Tissue effects of subclinical diode laser treatment of the retina. Arch Ophthalmol. 1998 Dec;116(12):1633-9. doi: 10.1001/archopht.116.12.1633. PubMed 9869794 ↗
  • Berger JW. Thermal modelling of micropulsed diode laser retinal photocoagulation. Lasers Surg Med. 1997;20(4):409-15. doi: 10.1002/(sici)1096-9101(1997)20:43.0.co;2-u. PubMed 9142680 ↗
  • Kuchar S, Moster MR, Reamer CB, Waisbourd M. Treatment outcomes of micropulse transscleral cyclophotocoagulation in advanced glaucoma. Lasers Med Sci. 2016 Feb;31(2):393-6. doi: 10.1007/s10103-015-1856-9. Epub 2015 Dec 29. PubMed 26714976 ↗
  • Hauber FA, Scherer WJ. Influence of total energy delivery on success rate after contact diode laser transscleral cyclophotocoagulation: a retrospective case review and meta-analysis. J Glaucoma. 2002 Aug;11(4):329-33. doi: 10.1097/00061198-200208000-00009. PubMed 12169970 ↗
  • Vernon SA, Koppens JM, Menon GJ, Negi AK. Diode laser cycloablation in adult glaucoma: long-term results of a standard protocol and review of current literature. Clin Exp Ophthalmol. 2006 Jul;34(5):411-20. doi: 10.1111/j.1442-9071.2006.01241.x. PubMed 16872335 ↗
  • Murphy CC, Burnett CA, Spry PG, Broadway DC, Diamond JP. A two centre study of the dose-response relation for transscleral diode laser cyclophotocoagulation in refractory glaucoma. Br J Ophthalmol. 2003 Oct;87(10):1252-7. doi: 10.1136/bjo.87.10.1252. PubMed 14507761 ↗
  • Meyer JJ, Lawrence SD. What's new in laser treatment for glaucoma? Curr Opin Ophthalmol. 2012 Mar;23(2):111-7. doi: 10.1097/ICU.0b013e32834f1887. PubMed 22186007 ↗
  • Marchand M, Singh H, Agoumi Y. Micropulse trans-scleral laser therapy outcomes for uncontrolled glaucoma: a prospective 18-month study. Can J Ophthalmol. 2021 Dec;56(6):371-378. doi: 10.1016/j.jcjo.2021.01.015. Epub 2021 Feb 10. PubMed 33577756 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 14, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03187418
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible party
Sponsor
First posted
Jun 15, 2017
Start date
Jun 19, 2017
Primary completion
Feb 15, 2020
Completion
Feb 15, 2020
Results posted
Oct 8, 2021
Last update
Oct 8, 2021

Study contacts

Harmanjit Singh, MD
principal investigator · Centre hospitalier de l'Université de Montréal (CHUM)
Michael Marchand, MD
principal investigator · Centre hospitalier de l'Université de Montréal (CHUM)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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