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da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

NCT04403022 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-06-21

No results posted yet for this study

Summary

To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.

Conditions

Interventions

DEVICE

Robotic Assisted Surgery

da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision

Sponsors & Collaborators

  • Intuitive Surgical

    lead INDUSTRY

Principal Investigators

  • Madhu L Gorrepati · Clinical Affairs Director

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2023-09-30
Completion
2028-11-30
FDA Device
Yes

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04403022 on ClinicalTrials.gov