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Status unknownNCT03323060Updated Aug 13, 2019

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

An observational study in Disease or Lesions of the Anus, Rectum, or Distal Colon, sponsored by Medrobotics Corporation. Status unknown at 2 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2019-08-13.

Primary conditionnone(registry's first term: Disease)No conditionIs this wrong?Disease describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Medrobotics Corporation · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Family-based
Time perspective
Prospective
Enrollment
20
Ages
22 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Disease or Lesions of the Anus, Rectum, or Distal Colon

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03

In context

Lead sponsor

Medrobotics Corporation is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Family-based
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceTransanal endoscopic surgical procedure

    Resection of tumors or lesions

    Also known as: Laparoscopy

06

What researchers measure

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

    Time frame: 0-24 hours

Secondary outcomes

  1. Performance of transanal surgical procedure

    Ability to complete the planned transanal surgical procedure using the Flex Robotic System, Flex Rectoscope and Flex compatible flexible instruments

    Time frame: 0-24 hours

07

Study locations

2 sites
  • 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
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2017 (actual). Primary completion is estimated for Dec 2019, 26 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2017
First posted
Oct 26, 2017
StartActual
Oct 11, 2017
Primary completionEst.
Dec 30, 2019
CompletionEst.
Dec 30, 2019
Last update
Aug 13, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03323060
Lead sponsor
Medrobotics Corporation
Responsible party
Sponsor
First posted
Oct 26, 2017
Start date
Oct 11, 2017
Primary completion
Dec 30, 2019 (estimated)
Completion
Dec 30, 2019 (estimated)
Last update
Aug 13, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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