NCT05672368

The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures

Phase II Study of the Da Vinci Single Port (SP) Robotic System for Abdominal and Pelvic Procedures

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port \[SP\]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the effectiveness and safety for abdominal and pelvic procedures of a single-port robotic device (da Vinci SP1098) that is Food and Drug Administration (FDA)-approved for other indications, specifically urological and transoral otolaryngology surgical procedures. OUTLINE: Patients undergo surgery using the da Vinci SP1098 robotic system on study.

Conditions

• Disease or Disorder

Interventions

Type	Name	Description
DEVICE	Robot-Assisted Surgery	Undergo surgery using the da Vinci SP device

Timeline

• Start date: 2024-04-26
• Primary completion: 2026-01-27
• Completion: 2026-01-27
• First posted: 2023-01-05
• Last updated: 2025-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study