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IS-001 Injection Phase-1 Safety, Tolerance and Pharmacokinetics

NCT03006237 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-03-05

No results posted yet for this study

Summary

A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001

Conditions

  • Hysterectomy
  • Surgery

Interventions

DRUG

IS-001

10mg, 20mg or 40 mg IV IS-001 drug administered during surgery

DEVICE

da Vinci® Si/Xi Surgical System

robot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging

Sponsors & Collaborators

  • Intuitive Surgical

    lead INDUSTRY

Principal Investigators

  • Richard Farnam, MD · Texas Urogynecology and Laser Surgery Center, Las Palmas Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03006237 on ClinicalTrials.gov