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

NCT ID: NCT05672368

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-26

Study Completion Date

2026-01-27

Brief Summary

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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

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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.

Conditions

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Disease or Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Device feasibility (da Vinci SP1098 robotic system)

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

Group Type EXPERIMENTAL

Robot-Assisted Surgery

Intervention Type DEVICE

Undergo surgery using the da Vinci SP device

Interventions

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Robot-Assisted Surgery

Undergo surgery using the da Vinci SP device

Intervention Type DEVICE

Other Intervention Names

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Navigation and Robotics Robot Assisted Robotic Surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mehdi Moslemi-Kebria

Role: PRINCIPAL_INVESTIGATOR

City of Hope Comprehensive Cancer Center

Locations

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City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Mehdi Moslemi-kebria

Role: primary

909-949-2242

Other Identifiers

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NCI-2022-10346

Identifier Type: REGISTRY

Identifier Source: secondary_id

22446

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22446

Identifier Type: -

Identifier Source: org_study_id

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