Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-12-31

Brief Summary

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The study is a prospective, single-center, single-arm unblinded clinical investigation. The aim of this study is to evaluate the performance and safety of da Vinci SP system. This study will entail a collection of demographics, preoperative, perioperative and postoperative outcomes of the patients into a database to follow this report on the outcomes, and notably answer questions to demonstrate the performance and safety of this surgical option.

All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the above study. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery

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Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participant arm

Group Type EXPERIMENTAL

single-port robotic surgery

Intervention Type DEVICE

Colorectal surgery using the da Vinci SP System will be performed via the umbilicus, McBurney's site or the reverse McBurney's site depending on the sites of lesion. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery.

Interventions

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single-port robotic surgery

Colorectal surgery using the da Vinci SP System will be performed via the umbilicus, McBurney's site or the reverse McBurney's site depending on the sites of lesion. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery.

Intervention Type DEVICE

Other Intervention Names

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da Vinci SP System

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Pathological confirm of colon or rectal cancer
* Clinical stage I-III
* Patient is a candidate for minimally invasive right hemicolectomy or anterior resection.
* ASA ≤3
* Performance status: ECOG 0-1

Exclusion Criteria

* Emergency surgery
* Patient has metastatic disease
* Patient has a bleeding or clotting disorder
* Uncontrolled illness, including active infection, symptomatic heart failure, unstable angina or cardiac arrhythmias, or psychiatric illness that would limit compliance with study requirements
* Previous laparotomy history
* Patient unable to provide informed consent
* Patient is pregnant
* BMI 35.0 or higher

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No