Post-Market Clinical Follow-Up to Access & Visualize the Anus, Rectum, & Distal Colon During Transanal Procedures
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
1 other identifier
observational
20
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2017
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2017
CompletedFirst Submitted
Initial submission to the registry
October 20, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedAugust 13, 2019
August 1, 2019
2.2 years
October 20, 2017
August 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Access and Visualization
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 Outcomes (1)
Performance of transanal surgical procedure
0-24 hours
Study Arms (1)
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
Interventions
Resection of tumors or lesions
Eligibility Criteria
Subjects ≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon
You may qualify if:
- ≥ 22 years of age
- Candidate for transanal procedures in the areas of the anus, rectum, and distal colon.
You may not qualify if:
- Candidates are excluded if they \< 22 years of age and do not meet criteria for transanal surgery in the anus, rectum, and distal colon
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Univsersity of Nevada School of Medicine
Las Vegas, Nevada, 89102, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2017
First Posted
October 26, 2017
Study Start
October 11, 2017
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
August 13, 2019
Record last verified: 2019-08