CompletedPhase 2

A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy

United States94 participantsStarted 2019-05-28

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexFEMALE

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Inclusion criteria

✓. Female subject is between the ages of 18 and 75, inclusive
✓. Subject is scheduled to undergo robotic gynecological surgery using a da Vinci® surgical system with Firefly® fluorescent imaging
✓. Subject is willing and able to provide informed consent
✓. Subject is considered capable of complying with study procedures

Exclusion criteria

✕. Subject is pregnant or nursing
✕. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

What they're measuring

Evaluate fluorescent intensity of ureter by signal to background analysis

Timeframe: 10 minutes

Evaluate fluorescent intensity of ureter by signal to background analysis

Timeframe: 30 minutes

Evaluate fluorescent intensity of ureter by signal to background analysis

Timeframe: 60 minutes

Trial details

NCT IDNCT03937505

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-08

View on ClinicalTrials.gov More Ureter Injury trials