An Early Phase 1 interventional study of ICG in Fibroid Uterus, Endometriosis and Uterus Myoma, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Northwestern University · Early Phase 1, Interventional, and Diagnostic
Among 156 studies in Leiomyoma with a site in United States — 20 open to participants now, 29 under way, 3 of them phase 3. Leiomyoma · United States.
Among the 156 studies in Leiomyoma with a site in United States, this one is the 65th largest by enrollment of the 121 interventional ones that give a count, is one of 5 that started in 2019, is one of 13 in phase 1, and was the 107th registered.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
Browse Leiomyoma studies →20 of the 156 studies in Leiomyoma with a site in United States are open now. Recruiting first, the newest first:
Northwestern University · Sites in United States
Ages 18–50 · Women only
Zenchi, Inc. · Sites in United States
Ages 20–45 · Women only
Medstar Health Research Institute · Sites in United States
Ages 18+ · Women only
Johns Hopkins University · Sites in United States
Ages 18+ · Women only
Thomas Jefferson University · Sites in United States
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 43 Leiomyoma studies recruiting now, 21 (49%) set no upper age limit and 21 (49%) stop at 75 or younger; 3 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 50 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
156 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 21 · Phase 3 32 · Phase 4 17
First in 1995; this study’s year is marked. 5 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 54 is below the median of 66 across 306 interventional studies indexed under Leiomyoma.
Median enrollment 57 across the 121 interventional studies, 187 across the 34 observational. Of the 113 that completed or were terminated, 59 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
71 of 156 have an industry lead sponsor. The 10 most frequent:
Northwestern University is the lead sponsor of 1,424 studies on the registry; 199 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Northwestern University has 6 studies filed under Leiomyoma — fewer than ten, so there is no comparison to draw.
8 of the studies in Leiomyoma with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07286188Northwestern UniversityEffect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy | 2026-12 |
| NCT06536517Johns Hopkins UniversityThe Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription. | 2026-12 |
| NCT04126824University of California, Los AngelesEffect of Addition of Steroids on Duration of Analgesia | 2026-12-30 |
| NCT05386615InSightecPost-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids | 2026-12-31 |
| NCT05739136Sumitomo Pharma Switzerland GmbHMYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy | 2027-05 |
Add all 8 to your calendar (.ics) → With an account.
Among the 156 studies in Leiomyoma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To assess the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries during gynecologic surgery
The purpose of this study is to determine the feasibility of intravenous ICG administration to facilitate assessments of ovarian vascular perfusion. Historically, assessment of ovarian perfusion has been performed visually or via ultrasound with Doppler evaluation. In patients with ovarian endometriomas, evidence of ovarian interstitial microvascular injury has been demonstrated similarly by the presence of low flow and high RI. The use of ICG to evaluate ovarian perfusion specifically has not been reported. The use of ICG for intraoperative perfusion assessment of the ovary could provide more information about the health of the ovary and inform the surgical approach to ovarian pathology.
ICG will be injected intravenously to assess ovarian perfusion in the presence or absence (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the ICG. The extent of perfusion will be determined using digital imaging software.
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:
ICG will be injected intravenously to assess ovarian perfusion in the presence or absence (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the ICG. The extent of perfusion will be determined using digital imaging software. ICG will be stored at the NM Investigational Pharmacy and administered intravenously by the anesthesiologist at the direction of the surgeon during surgical procedure.
Drug: ICG
Indocyanine green (ICG) is a Food and Drug (FDA)-approved tricarbocyanine dye that is fluorescent under near-infrared (NIR) light. ICG solutions for injection often contain sodium iodide. ICG is water soluble and when introduced intravenously, it is bound by plasma proteins, namely albumin. The intravascular half-life of ICG is 3-4 minutes with rapid hepatic clearance.
Also known as: Indocyanine green (ICG)
Assessment of ovarian perfusion after ICG administration via fluorescent imaging
The investigators will be assessing the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries by imaging. During surgery ICG will be administered intravenously via a peripheral or central line at the direction of the surgeon by the anesthesiologist. The injected amount will be a 3 mL solution of reconstituted ICG that contains a 7.5 mg dose of ICG. This will be followed by a 10 mL bolus of normal saline for injection per the manufacturer's recommendation. The total dose of dye injected should not exceed 2 mg/kg. Visibility of the ICG fluorescence should occur within 1-2 minutes with a duration of 20-120 minutes.
Time frame: 2 years
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2019 to primary completion in Nov 2022, 41 months.
Of 13 phase 1 interventional studies under Leiomyoma, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 41. This study's 41 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Indocyanine Green