NCT03006237

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-12-30
• Last updated: 2018-03-05

Locations

1 site across 1 country: United States