Study of a New Circular Anal Dilator

This study is currently recruiting participants.

Verified by University Hospitals of Cleveland, October 2008

Sponsors and Collaborators:	University Hospitals of Cleveland Ethicon, Inc.
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00693459

Purpose

The purpose of this research study is to test the effectiveness of a new anoscope used while performing a traditional hemorrhoidectomy.

Condition	Intervention	Phase
Hemorrhoids	Device: Circular Anal Dilator for Transanal Hemorrhoidectomy	Phase I Phase II

MedlinePlus related topics: Hemorrhoids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Feasibility Study of a New Circular Anal Dilator for Transanal Hemorrhoidectomy

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

Obtain phase I data confirming that this novel anoscope is safe and efficacious in the performance of a Ferguson hemorrhoidectomy. [ Time Frame: 1 year post-operative ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

The Circular Anal Dilator for Transanal Hemorrhoidectomy (product #CAD01) allows the standard of care Ferguson hemorrhoidectomy to be performed and does not alter the steps of the operation. The presumed advantages are the ability of the dilator to guide an accurate dissection and also to decrease the overall time it takes to perform hemorrhoidectomy.

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Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with internal or external symptomatic hemorrhoids.
Subjects who have failed, or are not suitable for office management of their hemorrhoids.
Subjects who are 18 years of age and older
Subjects of either gender
Subjects, who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent

Exclusion Criteria:

Subjects who have had previous hemorrhoid surgery.
Subjects with internal hemorrhoids that may be suitable for office management.
Subjects with incontinence.
Subjects with evidence of acute sepsis or the presence of a fistula.
Subjects with a medical condition that may interfere with the evaluation of safety or effectiveness of the study device.
Subjects who have another condition that in the opinion of the investigator precludes further participation in the study.
Subjects with an anal stricture.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693459

Contacts

Contact: Bridget O'Brien-Ermlich, RN, BSN, COCN	216-844-3602	bridget.ermlich@uhhospitals.org
Contact: Michelle Briehl, RN, BSN	216-844-4706	michelle.briehl@uhhospitals.org

Locations

United States, Ohio
University Hospitals of Cleveland Case Medical Center	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Bradley Champagne, MD 216-844-8942 bradley.champagne@uhhospitals.org
Contact: Lisa Sanuk, RN, BSN 216-844-7773 lisa.sanuk@uhhospitals.org
Sub-Investigator: Eric Marderstein, MD
Sub-Investigator: Vincent Obias, MD

Sponsors and Collaborators

University Hospitals of Cleveland

Ethicon, Inc.

Investigators

Principal Investigator:

Bradley Champagne, MD

University Hospitals of Cleveland

More Information

Responsible Party:	University Hospitals of Cleveland ( Bradley Champagne, MD )
Study ID Numbers:	07-07-06
Study First Received:	February 27, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00693459
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

Hemorrhoids

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Vascular Diseases

Hemorrhoids
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009