Perianal Operating Scope Feasibliity

NCT02807792 | Withdrawn FDA Device

• 1 other identifier: 1601M83061
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol will test a new prototype of a peri-anal access device, with increased flexible length and a captured operative field, for feasibility in patients immediately prior to their scheduled peri-anal procedure.

Conditions

Transanal Endoscopic Surgery

Keywords

Perianal surgery

Outcome Measures

Primary Outcomes (1)

• Visual assessment of operative field dimensions measured in centimeters

  The Outcome Measure Title implies the visual measurement that will be used to describe the potential operative field delineated by our experimental perianal access device. The description will, therefore, be primarily a qualitative visual assessment with the addition of estimated dimensions measured in centimeters for the length of the longitudinal and transverse fields encompassed by the blades of the access device. The collected measurement data will be aggregated, the numerical data averaged, and the visual perceptions integrated. The Time Frame for the individual study of each insertion will be two minutes or less. There is no chronic component to this feasibility analysis.

  Baseline

Study Arms (1)

Perianal access device

EXPERIMENTAL

Device: Perianal access device

Interventions

Perianal access device DEVICE

Perianal access device

Perianal access device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range 18 to 80
• In good health status
• Patients scheduled for a transanal procedure other than for anal lesions, e.g., hemorrhoids, fissures, abscesses

You may not qualify if:

• Patients with physical characteristics that distort the rectal sigmoid anatomy, e.g., spinal lesions.
• Patients considered too frail or ill by their physician to undergo a 5-10 minute prolongation of their procedure.
• Patients with known rectosigmoid infections.
• Patients with known rectosigmoid wall fragility.
• Patients with known rectosigmoid perforations.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

• Henry Buchwald, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 21, 2016
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

US (1)