- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07375017
easyEndoTM Powered Stapler Study
January 21, 2026 updated by: Ezisurg Medical Co. Ltd.
Evaluation of the Safety and Effectiveness of easyEndo™ Powered Single Use Powered Endoscopic Staplers and Cartridges in Laparoscopic Bariatric Procedures: an Observational, Post Market Study
The goal of this Observational, retrospective, uncontrolled is to evaluate the safety and performance of the easyEndo™ Powered Single Use Powered Endoscopic Staplers and Cartridges from EziSurg Medical used in laparoscopic bariatric surgery..
The main question it aims to answer the safety and performance of the device
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Doha Municipality
-
Doha, Doha Municipality, Qatar, 34146
- The Masters Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients have undergone laparoscopic bariatric surgery.
- The operation involves the application of easyEndo™ Powered Staplers and Cartridges for tissue cutting and suturing.
Exclusion Criteria:
- Pregnancy.
- Emergency operation (such as acute intestinal obstruction and gastrointestinal perforation).
- Assessed by the investigator, whose condition is poor and cannot tolerate the surgery.
- History of gastrointestinal surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: easyEndo™ Powered Single Use Powered Endoscopic Staplers and Cartridges
The easyEndoTM Powered Single Use Powered Endoscopic Staplers and Cartridges, which used together, are intended for transection, resection, and/or creation of anastomoses.
The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
|
laparoscopic bariatric surgery using easyEndo™ Powered Single Use Powered Endoscopic Staplers and Cartridges
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
stapling success rate
Time Frame: Perioperative/Periprocedural
|
no leakage intra-operation and post-operation
|
Perioperative/Periprocedural
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative complications
Time Frame: Perioperative/Periprocedural
|
postoperative complications
|
Perioperative/Periprocedural
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 21, 2025
Primary Completion (Actual)
January 8, 2026
Study Completion (Actual)
January 8, 2026
Study Registration Dates
First Submitted
January 21, 2026
First Submitted That Met QC Criteria
January 21, 2026
First Posted (Actual)
January 29, 2026
Study Record Updates
Last Update Posted (Actual)
January 29, 2026
Last Update Submitted That Met QC Criteria
January 21, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- PS-BS-QA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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