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

NCT05672368 | Recruiting Phase 2 DMC FDA Device

• 3 other identifiers: 22446NCI-2022-10346P30CA033572
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Disease or Disorder

Outcome Measures

Primary Outcomes (2)

• Conversion of operation to laparotomy

  The number and frequency will be reported with 95% confidence intervals.

  Within 30 days of operation

• Incidence of major surgical complications

  Will be assessed by Clavien-Dindo classification as grade 3 or higher. The number and frequency will be reported with 95% confidence intervals.

  Within 30 days of operation

Study Arms (1)

Device feasibility (da Vinci SP1098 robotic system)

EXPERIMENTAL

Patients undergo surgery using the da Vinci SP1098 robotic system on study.

Device: Robot-Assisted Surgery

Interventions

Robot-Assisted Surgery DEVICE

Undergo surgery using the da Vinci SP device

Also known as: Navigation and Robotics, Robot Assisted, Robotic Surgery

Device feasibility (da Vinci SP1098 robotic system)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Disease

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Mehdi Moslemi-Kebria

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: April 26, 2024
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): October 13, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)