Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure

NCT01169311 | Completed Results

• 1 other identifier: COVHEPH0021
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Trial Objectives The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set: overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events.

Conditions

Hemorrhoid

Keywords

Hemorrhoids; Hemorrhoid; grade II, III, IV

Outcome Measures

Primary Outcomes (1)

• Uneventful Creation of a Functional Staple Line at First Firing of Device

  Successful creation of staple line at first firing of device during hemorrhoidopexy

  about 20 minutes for procedure

Secondary Outcomes (8)

• OR Time

  Day 0 - Time of stop minus time of start

• Intra-Operative Bleeding Requiring Intervention

  Day 0 - time of surgery

• Length of Stay

  Day 0, time of discharge minus time of admission

• Time to Return to Normal Activity

  30 days post op

• Incidence of Stapler Malfunction or Misfires

  about 20 minutes for procedure

Study Arms (1)

HEEA Stapler

EXPERIMENTAL

hemorrhoidopexy using Covidien EEA Hemorrhoid and Prolapse Stapling Set

Device: Hemorrhoidopexy

Interventions

Hemorrhoidopexy DEVICE

Also known as: Covidien EEA Hemorrhoid and Prolapse Stapling set

HEEA Stapler

Eligibility Criteria

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

You may qualify if:

• Able to understand and sign Informed Consent Form
• The participant must be 18-80 years of age.
• The participant has (symptomatic) Grade 2-4 Hemorrhoids and is eligible for stapled hemorrhoidopexy.

You may not qualify if:

• The procedure is needed as revision hemorrhoid surgery.
• The participant is pregnant.
• The participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date.
• The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
• The participant has a history of drug or alcohol abuse.
• The participant has a history of venous thrombosis or pulmonary embolism.
• The participant has a history of coagulopathy.
• The participant is taking aspirin, anti-coagulation and/or anti platelet therapies (e.g.: Warfarin, Levonox) within the last 7 days prior to the planned surgery date
• The participant has a history of fecal incontinence.
• The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Hemorrhoids; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Tam LaFleur
• Organization: Covidien

tam.lafleur@covidien.com

203-821-4744

Study Officials

• Sang Lee, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 26, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 6, 2014
• Results First Posted: October 6, 2014

Record last verified: 2014-09

Locations

US (1)