At a glance
ClinicalIndex Comparison RecordN/ACompleted· 149 enrolled
Drug / intervention
EEA Hemorrhoid and Prolapse Stapling Set +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A clinical study evaluating EEA Hemorrhoid and Prolapse Stapling Set and Endosurgery Proximate PPH03 Stapling Set for Hemorrhoids. Completed, enrolled 149 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhoids
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedMar 2011
Primary CompletionAug 2012
Study CompletionJan 2013
TodayJul 2026
First PostedMar 2, 2011
Enrollment StartJan 1, 2011
Primary CompletionAug 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.3 years ago
Interventions
EEA Hemorrhoid and Prolapse Stapling Setdevice
Surgical device
Endosurgery Proximate PPH03 Stapling Setdevice
Surgical device