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A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy
NCT03937505 · View on ClinicalTrials.gov ↗
Study Summary
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified optimal dose in study participants.
Conditions Studied
Interventions
- DRUG IS-001
- DRUG No treatment
Study Locations (3)
Texas
- St.David's Medical Center — Austin
- Las Palmas Medical Center — El Paso
District of Columbia
- George Washington University Hospital — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2019-05-28 |
| Est. Completion | 2021-07-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03937505
The ClinicalTrials.gov registry entry for NCT03937505 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intuitive Surgical, which has 53 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Ureter Injury appearing as the primary indexed condition, and to 2 interventions — of which IS-001 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03937505 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Texas, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03937505 about?
NCT03937505 is a clinical study titled "A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy". This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for...
What is the current status of trial NCT03937505?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2019-05-28. Estimated completion is 2021-07-22.
What conditions does trial NCT03937505 study?
This clinical trial studies the following conditions: Ureter Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03937505?
The interventions under investigation include: IS-001 (DRUG), No treatment (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03937505?
This trial is sponsored by Intuitive Surgical, which has 53 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03937505 being conducted?
This trial has 3 study locations across District of Columbia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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