An interventional study of Zenflow Spring System in Benign Prostatic Hyperplasia, sponsored by Zenflow, Inc.. Status unknown at 3 sites in 2 countries. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-06.
Sponsored by Zenflow, Inc. · Not applicable, Interventional, and Treatment
This is a First in Human study to assess the feasibility, safety and effectiveness of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
The purpose of the Zenflow Study is to evaluate the feasibility and safety of a novel prostatic urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). Effectiveness will also be measured. It is intended that the features of the Zenflow Spring will provide an effective office-based treatment and management therapy for BPH with little or no side effects.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 30 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Zenflow, Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
New Zealand only: A maximum of 5 participants in acute or chronic urinary retention may be included in the study provided they meet other entry criteria. Exclusion exemptions for these patients are described in 4a, 5a and they are exempt from #6.
Participants will be excluded from participating in this trial if they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives intervention with the Zenflow Spring System.
Device: Zenflow Spring System
The Zenflow Spring is a nitinol urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). The device is intended to be a permanent implant however it may be removed if necessary.
Device Success defined as both 1) deliverability of the implant and 2) freedom from unanticipated adverse events (UAEs) not listed in the protocol or AEs that meet the protocol definition of Serious AEs.
Frequency of Device Success is assessed by subject, for both successful device placement in the target anatomy and absence of serious or unanticipated adverse events through discharge.
Time frame: Intraoperative
Occurrence of device and/or procedure related Adverse Events as determined by investigator and independent medical reviewer
Frequency and severity of any device or procedure related adverse events, by subject.
Time frame: Intraoperative
Occurrence of Adverse Event specific to indwelling catheterization, descriptive analysis
Frequency of indwelling catheterization = or \> 7 days following placement of the investigational device.
Time frame: Seven days following implantation of the investigational device
Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS)
Subjects should demonstrate improvement of \> or = to 3 point reduction from baseline measurement.
Time frame: 3 months following device placement
Assessment of Sexual Health using the Sexual Health in Men (SHIM) questionnaire
Observational assessment of subject scores on SHIM at the 6 months and 12 months visit, compared to baseline.
Time frame: 6 months, 12-,24-,36-, months post implantation
Assessment of Incontinence, using the Incontinence Severity Index (ISI) questionnaire
Observational assessment of subject scores on ISI at 2 weeks, 1 month and 3 months compared to baseline.
Time frame: 2 weeks, 1 month, 3 months
Observation of pain using a validated Visual Analogue Scale (VAS) questionnaire
Observational assessment of subject reports of pain on the VAS questionnaire, at discharge and follow up visits up to 3 months, compared to baseline.
Time frame: through 3 month follow-up
Improvement in Uroflowmetry compared to baseline
Uroflowmetry is measured at 3 months post implantation and compared to baseline
Time frame: 3-, 6-, 12-, 24-, 36-months post implantation
Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS)
Observation of IPSS scores compared to baseline at 12 months follow up.
Time frame: 12 months 24 months and 36 months
Effectiveness of the treatment by assessing need for further treatment to alleviate symptoms of BPH.
Observation of incidence of repeat invasive treatment for LUTS through 12 months post-procedure
Time frame: 12 months 24 months and 36 months
Plan to share: Undecided
The record gives a start of Apr 2016, a primary completion of Dec 2019 and a completion of Jan 2020. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Zenflow, Inc.