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

December 28, 2023 updated by: City of Hope Medical Center

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Mehdi Moslemi-kebria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device feasibility (da Vinci SP1098 robotic system)
Patients undergo surgery using the da Vinci SP1098 robotic system on study.
Device: Robot-Assisted Surgery
Undergo surgery using the da Vinci SP device
Other Names:
  • Navigation and Robotics
  • Robot Assisted
  • Robotic Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion of operation to laparotomy
Time Frame: Within 30 days of operation
The number and frequency will be reported with 95% confidence intervals.
Within 30 days of operation
Incidence of major surgical complications
Time Frame: 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.
Within 30 days of operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mehdi Moslemi-Kebria, City of Hope Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 29, 2024

Primary Completion (Estimated)

January 27, 2025

Study Completion (Estimated)

January 27, 2025

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22446 (Other Identifier: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2022-10346 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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