Clinical trial · Interventional
Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure
A Prospective, Multi-Center Investigation Of The Safety And Performance Of The Covidien EEA™ Hemorrhoid And Prolapse Stapling Set With DST Series™ Technology Im A Hemorrhoidopexy Procedure
NCT01169311CI-TRIAL-00015781completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemorrhoid | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hemorrhoidopexy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HEEA Stapler
- description
- hemorrhoidopexy using Covidien EEA Hemorrhoid and Prolapse Stapling Set
- interventionNames
- Device: Hemorrhoidopexy
Primary outcomes (1)
- measure
- Uneventful Creation of a Functional Staple Line at First Firing of Device
- timeFrame
- about 20 minutes for procedure
- description
- Successful creation of staple line at first firing of device during hemorrhoidopexy
Secondary outcomes (8)
- measure
- OR Time
- timeFrame
- Day 0 - Time of stop minus time of start
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.