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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05672368

Enrollment

Registered

2023-01-05

Start date

2024-04-26

Completion date

2026-10-13

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease or Disorder

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.

Detailed description

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.

Interventions

DEVICERobot-Assisted Surgery

Undergo surgery using the da Vinci SP device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Conversion of operation to laparotomy	Within 30 days of operation	The number and frequency will be reported with 95% confidence intervals.
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMehdi Moslemi-Kebria

City of Hope Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026