Recruiting
Phase 2

da Vinci System

Sponsor:

City of Hope Medical Center

Code:

NCT05672368

Conditions

Disease or Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Robot-Assisted Surgery

Study Details

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.

Conditions

Disease or Disorder

Study ID

NCT05672368

Start date

Apr 26, 2024

Status verified date

Oct, 2026

Completion date

Sep 21, 2027

Anticipated

Primary completion date

Sep 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

33 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Device feasibility (da Vinci SP1098 robotic system)

Patients undergo surgery using the da Vinci SP1098 robotic system on study.

Interventions

Robot-Assisted Surgery

Undergo surgery using the da Vinci SP device

Primary outcome measure

  • Conversion of operation to laparotomy [ Time Frame: Within 30 days of operation ]
  • Incidence of major surgical complications [ Time Frame: Within 30 days of operation ]

Central Contacts and Locations

Locations

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Mehdi Moslemi-kebria

909-949-2242mkebria@COH.org

Principal Investigator:

Mehdi Moslemi-kebria

More Information

Sponsor

City of Hope Medical Center

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.