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

Conditions

• Disease or Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Robot-Assisted Surgery — DEVICE
  Undergo surgery using the da Vinci SP device

Study Details

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.

Key Dates

Start date

Apr 26, 2024

Status verified

Apr 2026

Primary completion

Oct 13, 2026

Completion

Oct 13, 2026

Study Design

Enrollment

33 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• Experimental: Device feasibility (da Vinci SP1098 robotic system)
  Patients undergo surgery using the da Vinci SP1098 robotic system on study.

Primary Outcome Measure

Conversion of operation to laparotomy [ Time Frame: Within 30 days of operation ]

Locations (1)

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