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NCT Number: NCT05672368

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

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Key information

Conditions

Disease or Disorder Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location status: Recruiting

Location contact

Mehdi Moslemi-kebria

CONTACT

[email protected]

909-949-2242

Mehdi Moslemi-kebria

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-Assisted Surgery

Device

Undergo surgery using the da Vinci SP device

Other names: Navigation and Robotics, Robot Assisted, Robotic Surgery

Primary outcomes

  1. Conversion of operation to laparotomy

    Time frame: Within 30 days of operation

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

  2. 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2023
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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