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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05672368
Collaborator
National Cancer Institute (NCI) (NIH)
33
Enrollment
1
Location
1
Arm
6.9
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Robot-Assisted Surgery
 Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Phase II Study of the Da Vinci Single Port (SP) Robotic System for Abdominal and Pelvic Procedures
Anticipated Study Start Date :
Jun 29, 2023
Anticipated Primary Completion Date :
Jan 26, 2024
Anticipated Study Completion Date :
Jan 26, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Conversion of operation to laparotomy [Within 30 days of operation]

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

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Comprehensive Cancer Center Duarte California United States 91010

    Sponsors and Collaborators

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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT05672368
    Other Study ID Numbers:
    • 22446
    • NCI-2022-10346
    • 22446
    • P30CA033572
    First Posted:
    Jan 5, 2023
    Last Update Posted:
    Jan 5, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Disease

    Study Results

    No Results Posted as of Jan 5, 2023