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A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Colorectal Surgeries（SPiM-RWS-CR）

NCT ID: NCT06141421

Last Updated: 2024-12-12

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

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-28

Study Completion Date

2024-08-15

Brief Summary

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A real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robot-assisted colorectal surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.

English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.

Detailed Description

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Conditions

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Single-Port Colorectal Surgeries

Keywords

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Single-Port Colorectal Surgeries low anterior resection of the rectum with or without total mesorectal excision right hemicolectomy, left hemicolectomy and sigmoidectomy with or without transanal total mesocolic excision and central blood vessel ligation transanal minimally invasive surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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RWS study for SP CR Surgeries da Vinci SP Surgical System(SP1098)

procedure

Intervention Type PROCEDURE

procedure

Interventions

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procedure

procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Subjects who have received or plan to receive colorectal surgeries with the SP single-port robot, such as low anterior resection of the rectum with or without total mesorectal excision; right hemicolectomy, left hemicolectomy and sigmoidectomy with or without transanal total mesocolic excision and central blood vessel ligation; and transanal minimally invasive surgery.
2. Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).

Exclusion Criteria

1. Patients with missing data on the primary endpoint in retrospective cases;
2. Subjects having any contraindications of single-port robot surgery;
3. The intraoperative anatomy determined that minimally invasive surgery was not suitable;
4. Patients who are considered inappropriate to participate in this study by investigator.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Ren

Pro.Zhao

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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ISFMT-SP-003

Identifier Type: -

Identifier Source: org_study_id