Perianal Operating Scope Feasibliity

NCT ID: NCT02807792

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2018-07-31

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.

Detailed Description

Research Methods: The insertion of the modified access device in five patients before their planned peri-anal procedure, which will subsequently be performed with standard instruments, will allow us to observe the ease of insertion, the expansion of the blades, and the creation of the operative field achieved. If necessary, we will modify our design based on these findings. When a successful, operating room prototype is established, the device will be suitable for clinical use and the stated benefits thereof.

Conditions

Transanal Endoscopic Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Perianal access device

Group Type: EXPERIMENTAL

Perianal access device

Intervention Type: DEVICE

Perianal access device

Interventions

Perianal access device

Perianal access device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Patients with physical characteristics that distort the rectal sigmoid anatomy, e.g., spinal lesions.
• Patients considerable unsuitable for inclusion in the study by their colorectal surgeon.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry Buchwald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1601M83061

Identifier Type: -

Identifier Source: org_study_id