NCT03937505

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

May 28, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2021

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

2.1 years

First QC Date

April 29, 2019

Last Update Submit

August 3, 2021

Conditions

Ureter Injury

Keywords

robotic-assisted surgeryminimally invasive surgery

Outcome Measures

Primary Outcomes (3)

  • Evaluate fluorescent intensity of ureter by signal to background analysis

    Fluorescent intensity of ureter evaluated as signal to background

    10 minutes

  • Evaluate fluorescent intensity of ureter by signal to background analysis

    Fluorescent intensity of ureter evaluated as signal to background

    30 minutes

  • Evaluate fluorescent intensity of ureter by signal to background analysis

    Fluorescent intensity of ureter evaluated as signal to background

    60 minutes

Secondary Outcomes (25)

  • Safety 12-Lead EKG Change from Baseline

    6 hours

  • Incidence of abnormal blood work in tests results

    24 hours

  • Incidence of abnormal blood work in tests results

    14 days

  • Incidence of abnormal blood work in tests results

    24 hours

  • Incidence of abnormal blood work in tests results

    14 days

  • +20 more secondary outcomes

Study Arms (2)

Dose-escalation

EXPERIMENTAL

Dose-cohort escalation of single intravenous injection of IS-001 starting with 20 mg (n=8), escalating in 20 mg increments until optimal dose is determined.

Drug: IS-001

Optimal dose-characterization

EXPERIMENTAL

Single intravenous injection of IS-001 at the optimal dose will be administered to subjects assigned to the treatment group. Safety control subjects will not receive any study drug but will undergo robotic surgery and all associated safety assessment clinical trial procedures.

Drug: IS-001Drug: No treatment

Interventions

IS-001DRUG

intravenous injection of IS-001 investigational drug

Dose-escalationOptimal dose-characterization
No treatmentDRUG

no drug injection

Optimal dose-characterization

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subject is pregnant or nursing
  • Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • \. Subject is already enrolled in another investigational study 5. Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

St.David's Medical Center

Austin, Texas, 78758, United States

Location

Las Palmas Medical Center

El Paso, Texas, 79902, United States

Location

MeSH Terms

Interventions

IS 001

Study Officials

  • Richard Farnam, MD

    Las Palmas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Stage A is a dose-cohort escalation to determine optimal efficacious dose, Stage B is an expanded safety and efficacy evaluation of the optimal dose with a no-drug safety control group
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 3, 2019

Study Start

May 28, 2019

Primary Completion

July 8, 2021

Study Completion

July 22, 2021

Last Updated

August 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)