Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids (HEMOSTASIS)
This study is currently recruiting participants.
Verified October 2011 by Covidien
Sponsor:
Covidien
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01306877
First received: January 28, 2011
Last updated: August 8, 2012
Last verified: October 2011
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Purpose
The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemorrhoids |
Device: EEA Hemorrhoid and Prolapse Stapling Set Device: Endosurgery Proximate PPH03 Stapling Set |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Prospective Single Blinded Randomized Controlled Trial Comparing The Covidien EEA™ Hemorrhoid and Prolapse Stapling Set With DST Series™ Technology Vs. Ethicon PPH03 In A Hemorrhoidopexy Procedure (HEMOSTASIS) |
Resource links provided by NLM:
Further study details as provided by Covidien:
Primary Outcome Measures:
- Intraoperative bleeding [ Time Frame: Intraoperative period (January 2011- March 2012) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Post operative pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Overall quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Location of the staple line [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Number of patients with device related adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Length of stay [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Operative Room (OR) time [ Time Frame: Intraoperative period (January 2011- March 2012) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: EEA Hemorrhoid and Prolapse Stapling Set |
Device: EEA Hemorrhoid and Prolapse Stapling Set
Surgical device
|
| Active Comparator: Endosurgery Proximate PPH03 Stapling Set |
Device: Endosurgery Proximate PPH03 Stapling Set
Surgical device
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The subject is able to understand and sign Informed Consent Form
- The subject is between 18-85 years of age.
- The subject has (symptomatic) Grade 2-3 Hemorrhoids and is eligible for stapled hemorrhoidopexy
Exclusion Criteria:
- The procedure is needed as revision hemorrhoid surgery.
- Any female patient, who is pregnant, suspected pregnant, or nursing.
- 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 1 year 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 has taken aspirin, anti-coagulation and/or anti platelet therapies (e.g. Warfarin, Lovenox) within 7 days prior to the planned date of surgery.
- The participant has a history of fecal incontinence
- The participant has had injection therapy, infrared laser treatment or rubber band ligation for treatment of hemorrhoids within 1 month of screening
- The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306877
Contacts
| Contact: Tam LaFleur | 203-821-4744 | tam.lafleur@covidien.com |
| Contact: Jessica Chowaniec | 203-821-4741 | jessica.chowaniec@covidien.com |
Locations
| United States, Florida | |
| USF Tampa General Hospital Dept of Surgery | Recruiting |
| Tampa, Florida, United States, 33606 | |
Sponsors and Collaborators
Covidien
Investigators
| Principal Investigator: | Jorge Marcet, MD | University of South Florida |
More Information
No publications provided
| Responsible Party: | Covidien |
| ClinicalTrials.gov Identifier: | NCT01306877 History of Changes |
| Other Study ID Numbers: | COVHEPH0109 |
| Study First Received: | January 28, 2011 |
| Last Updated: | August 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Covidien:
|
hemorrhoid hemorrhoid stapler |
Additional relevant MeSH terms:
|
Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013