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

Phase 2

Recruiting

• Conditions: Disease or Disorder

• Registration Number: NCT05672368
• Lead Sponsor: City of Hope Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-05
• Study Start: 2024-04-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-01-27
• Study Completion: 2026-01-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Documented informed consent of the participant and/or legally authorized representative
• Any patient scheduled to undergo robot-assisted abdominal or pelvic procedures
• Age > 18 years

Exclusion Criteria

• Body mass index (BMI) > 45
• Contraindications to minimally invasive surgery including chronic obstructive pulmonary disorders
• Past history of failed attempt of minimally invasive abdominal or pelvic surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of major surgical complications	Within 30 days of operation	Will be assessed by Clavien-Dindo classification as grade 3 or higher. The number and frequency will be reported with 95% confidence intervals.
Conversion of operation to laparotomy	Within 30 days of operation	The number and frequency will be reported with 95% confidence intervals.

Trial Locations

Locations (1)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States