NCT01306877

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 29, 2014

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

1.6 years

First QC Date

January 28, 2011

Results QC Date

February 20, 2014

Last Update Submit

October 24, 2014

Conditions

Hemorrhoids

Keywords

hemorrhoidhemorrhoid stapler

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Bleeding

    Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow.

    Day 0 - time of surgery

Secondary Outcomes (6)

  • Post Operative Pain - (PI-NIRS)

    Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180

  • Post-Operative Pain (Analgesic Intake)

    Day 0, 1 week, 2 week, 1 month, 3 month, 6 month

  • Overall Quality of Life - General Health Score

    Day 0 minus 60, 1 week, 1 month, 3 months, 6 months

  • Location of the Staple Line

    Day 0

  • Length of Stay

    Day 0 time of discharge minus time of admission

  • +1 more secondary outcomes

Study Arms (2)

EEA Hemorrhoid and Prolapse Stapling Set

EXPERIMENTAL
Device: EEA Hemorrhoid and Prolapse Stapling Set

Endosurgery Proximate PPH03 Stapling Set

ACTIVE COMPARATOR
Device: Endosurgery Proximate PPH03 Stapling Set

Interventions

EEA Hemorrhoid and Prolapse Stapling SetDEVICE

Surgical device

EEA Hemorrhoid and Prolapse Stapling Set
Endosurgery Proximate PPH03 Stapling SetDEVICE

Surgical device

Endosurgery Proximate PPH03 Stapling Set

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USF Tampa General Hospital Dept of Surgery

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Tam LaFleur, Clinical Project Manager
Organization
Covidien
tam.lafleur@covidien.com
203-821-4744

Study Officials

  • Jorge Marcet, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2011

First Posted

March 2, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2012

Study Completion

January 1, 2013

Last Updated

October 29, 2014

Results First Posted

October 29, 2014

Record last verified: 2014-10

Locations

US(1)