Perianal Operating Scope Feasibliity

Transanal Endoscopic Surgery Clinical Trial

Official title:

Perianal Operating Scope Feasibility

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02807792
• Other study ID #: 1601M83061
• Status: Withdrawn
• Phase: N/A
• First received: May 18, 2016
• Last updated: April 25, 2017
• Start date: July 2017
• Est. completion date: July 2018

Study information

• Verified date: April 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transanal Endoscopic Surgery

Intervention

Device:
• Perianal access device
Perianal access device

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   J Med Devices 7(2), 020947 (June 21, 2013)