Study of a New Circular Anal Dilator

NCT00693459 | Completed

• 1 other identifier: 07-07-06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemorrhoids

Keywords

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of the new device by the number of participants with Adverse Events

  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

  1 year post-operative

Secondary Outcomes (1)

• Evaluate the efficacy of the new device by the number of participants with Adverse Events

  1 year post operative

Study Arms (1)

Circular anal dilator

OTHER

Circular anal dilator group-An anoscope has been developed that outlines the precise path for hemorrhoid excision. This instrument allows a modified Ferguson hemorrhoidectomy to be performed and does not alter the steps of the operation.

Device: Circular Anal Dilator for Transanal Hemorrhoidectomy

Interventions

Circular Anal Dilator for Transanal Hemorrhoidectomy DEVICE

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.

Also known as: Chemo 2

Circular anal dilator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Ethicon, Inc.: collaborator

Study Sites (1)

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bradley Champagne, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: June 9, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 15, 2022

Record last verified: 2013-01

Locations

US (1)