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

NCT ID: NCT03006237

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-12-31

Brief Summary

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

Detailed Description

A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging

Conditions

Hysterectomy; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

IV IS-001 drug

IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System

Group Type: EXPERIMENTAL

IS-001

Intervention Type: DRUG

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

da Vinci® Si/Xi Surgical System

Intervention Type: DEVICE

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

Interventions

IS-001

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

Intervention Type: DRUG

da Vinci® Si/Xi Surgical System

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is between the ages of 18 and 65.

2. Subject is scheduled to undergo robotic hysterectomy using a da Vinci® Si/Xi surgical system with Firefly® fluorescent imaging.

3. Subject is willing and able to provide informed consent.

4. Subject is considered capable of complying with study procedures.

5. Subject has no medical history of liver or kidney disease.

6. Subject has no evidence of NYHA Class II-IV cardiac disease.

7. Subject has recent (< 3 months) clinical hematology (CBC) values within the acceptable values reference range.

8. Subject has recent (< 3 months) clinical serum chemistry (CMP) values within the acceptable values reference range.

Exclusion Criteria

1. Subject is pregnant or nursing.

2. Subject has a history of alcoholism.

3. Subject has a history of drug abuse.

4. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

5. Subject has known human immunodeficiency virus (HIV) infection.

6. Subject has been diagnosed with or treated for cancer in the last 2 years.

7. Subject has a total body weight < 32 kg.

8. Subject has after 5 minutes of supine rest a diastolic blood pressure ≥100 mmHg and/or a systolic blood pressure ≥160 mmHg.

9. Subject has after 5 minutes of supine rest a resting heart rate ≤35 or ≥115 bpm.

10. Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data or represents an unacceptable safety liability.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Intuitive Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Farnam, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Urogynecology and Laser Surgery Center, Las Palmas Medical Center

Locations

Las Palmas Medical Center

El Paso, Texas, United States

Countries

United States

References

Farnam RW, Arms RG, Klaassen AH, Sorger JM. Intraoperative ureter visualization using a near-infrared imaging agent. J Biomed Opt. 2019 Jun;24(6):1-8. doi: 10.1117/1.JBO.24.6.066004.

Reference Type: DERIVED

PMID: 31215195 (View on PubMed)

Other Identifiers

ISI-001-01

Identifier Type: -

Identifier Source: org_study_id