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Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery

NCT05321134 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-05

No results posted yet for this study

Summary

Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.

Conditions

  • Colo-rectal Cancer
  • Rectal Prolapse
  • Colostomy Stoma
  • Colorectal Disorders

Interventions

DEVICE

Single port robotic colorectal surgical procedure

After screening and counseling, study subjects who wish to participate will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the alternate Intuitive Da Vinci Single Port SP system rather than the currently used multiport system, (Intuitive Da Vinci Multiport Xi System). Using standardized case report forms, the investigators will track clinical parameters and describe the safety \& quality event rate for SP platform transabdominal and transanal colorectal operations.

Sponsors & Collaborators

  • University of California, San Francisco

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • Henry Ford Hospital

    collaborator OTHER

  • University of Massachusetts, Worcester

    collaborator OTHER

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Ankit Sarin, MD · University of California, Davis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2026-04-30
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05321134 on ClinicalTrials.gov