Post-Market Clinical Follow-Up to Access & Visualize the Anus, Rectum, & Distal Colon During Transanal Procedures

August 12, 2019 updated by: Medrobotics Corporation

A Multicenter Post-Market Clinical Follow-Up of the Medrobotics Flex Robotic System and Flex Rectoscope Used for Accessing and Visualizing the Anus, Rectum, and Distal Colon During Transanal Procedures

To assess the safety and performance of the Medrobotics Flex Robotic System and Flex Rectoscope for accessing and visualizing the Anus, Rectum, and Distal Colon when used for Transanal procedures

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Univsersity of Nevada School of Medicine
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects ≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon

Description

Inclusion Criteria:

  • ≥ 22 years of age
  • Candidate for transanal procedures in the areas of the anus, rectum, and distal colon.

Exclusion Criteria:

  • Candidates are excluded if they < 22 years of age and do not meet criteria for transanal surgery in the anus, rectum, and distal colon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Male and/or females ≥ 22 yrs old
≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon Transanal endoscopic surgical procedure
Device: Transanal endoscopic surgical procedure
Resection of tumors or lesions
Other Names:
  • Laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Access and Visualization
Time Frame: 0-24 hours
Ability to access/touch with compatible flexible instruments and visualize/see with the scope/camera each of the four anatomical locations in the anus, rectum, and distal colon. The 4 areas to be accessed/touched and visualized/seen from the most proximal to the most distal are; Lower Rectum, Mid Rectum, Upper Rectum, Rectosigmoid Junction
0-24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of transanal surgical procedure
Time Frame: 0-24 hours
Ability to complete the planned transanal surgical procedure using the Flex Robotic System, Flex Rectoscope and Flex compatible flexible instruments
0-24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medrobotics Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2017

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (Actual)

October 26, 2017

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • FLX-CRC-PMK-US-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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