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

Last updated: May 21, 2024
Sponsor: City of Hope Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Robot-Assisted Surgery

Clinical Study ID

NCT05672368
22446
NCI-2022-10346
P30CA033572
22446
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented informed consent of the participant and/or legally authorizedrepresentative

  • Any patient scheduled to undergo robot-assisted abdominal or pelvic procedures

  • Age > 18 years

Exclusion

Exclusion Criteria:

  • Body mass index (BMI) > 45

  • Contraindications to minimally invasive surgery including chronic obstructivepulmonary disorders

  • Past history of failed attempt of minimally invasive abdominal or pelvic surgery

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: Robot-Assisted Surgery
Phase: 2
Study Start date:
April 26, 2024
Estimated Completion Date:
January 27, 2025

Study 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.

Connect with a study center

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Active - Recruiting

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