Study of a New Circular Anal Dilator

This study has been completed.
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Brad Champagne, MD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00693459
First received: February 27, 2008
Last updated: January 16, 2013
Last verified: January 2013
  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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of a New Circular Anal Dilator for Transanal Hemorrhoidectomy

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Evaluate the safety of the new device by the number of participants with Adverse Events [ Time Frame: 1 year post-operative ] [ Designated as safety issue: Yes ]
    This study will be monitored to ensure the identification, documentation and analysis of all adverse events in regards to safety and efficacy of the new device. All adverse events, unforeseen or otherwise will be recorded as data. Information will be reported on the 1)Visual Analog Pain scores, 2)Incontinence score, using the Wexner Oliveira score, 3) Presence of Stenosis 4) Continued bleeding or symptoms, 5) Wound Infection, 6) Bladder Retention


Secondary Outcome Measures:
  • Evaluate the efficacy of the new device by the number of participants with Adverse Events [ Time Frame: 1 year post operative ] [ Designated as safety issue: Yes ]
    This study will be monitored to ensure the identification, documentation and analysis of all adverse events in regards to safety and efficacy of the new device. All adverse events, unforeseen or otherwise will be recorded as data. Information will be reported on the 1)Visual Analog Pain scores, 2)Incontinence score, using the Wexner Oliveira score, 3) Presence of Stenosis 4) Continued bleeding or symptoms, 5) Wound Infection, 6) Bladder Retention


Enrollment: 20
Study Start Date: May 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Circular Anal Dilator for Transanal Hemorrhoidectomy
    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.
    Other Name: Chemo 2
  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospital Case Medical Center
Ethicon, Inc.
Investigators
Principal Investigator: Bradley Champagne, MD University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Brad Champagne, MD, Principal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00693459     History of Changes
Other Study ID Numbers: 07-07-06
Study First Received: February 27, 2008
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Hemorrhoids

Additional relevant MeSH terms:
Hemorrhoids
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014