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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04422236
Other study ID # DM-Delta-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 28, 2020
Est. completion date May 31, 2025

Study information

Verified date May 2023
Source Duomed
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during laparoscopic bariatric surgery. The goal of the study will be achieved by assessing the device performance and by reporting of peri- and postoperative complications in a prospectively maintained database.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date May 31, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient = 18 years of age at registry entry. - Patient and investigator signed and dated the informed consent form prior to the index-procedure. - Patient has a BMI = 35 kg/m2, with one or more related co-morbidities. - Patient has a BMI = 40 kg/m2. - Patient is eligible for laparoscopic bariatric surgery. Exclusion Criteria: - Patient is unable / unwilling to provide informed consent. - Patient has a history of bariatric surgery. - Patient is unable to comply with the registry protocol or proposed follow-up visits. - Patient has a contra-indication for laparoscopic bariatric surgery.

Study Design


Intervention

Device:
easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creation of anastomoses during laparoscopic bariatric surgery, manufactured by Ezisurg Medical.

Locations

Country Name City State
Belgium AZ Delta vzw Roeselare

Sponsors (1)

Lead Sponsor Collaborator
Duomed

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. Conversion rate, number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. At index procedure
Primary To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. Number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. At discharge, up to 1 week
Primary To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. Number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. Follow-up 1: 3 weeks after the procedure
Primary To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. Number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. Follow-up 2: 8 weeks after the procedure
Primary To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. Number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. Follow-up 3: 6 months after the procedure
Primary To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. Number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. Follow-up 4: 12 months after the procedure
Primary To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. Number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. Follow-up 5: 18 months after the procedure
Primary To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. Number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. Follow-up 6: 24 months after the procedure
Secondary Device performance Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to open laparotomy. At index procedure
Secondary Device performance Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.). At index procedure
Secondary Clinical efficacy Weight loss Follow-up 1: 3 weeks after the procedure
Secondary Clinical efficacy Weight loss Follow-up 2: 8 weeks after the procedure
Secondary Clinical efficacy Weight loss Follow-up 3: 6 months after the procedure
Secondary Clinical efficacy Weight loss Follow-up 4: 12 months after the procedure
Secondary Clinical efficacy Weight loss Follow-up 5: 18 months after the procedure
Secondary Clinical efficacy Weight loss Follow-up 6: 24 months after the procedure
Secondary Clinical efficacy Comorbidity Follow-up 4: 12 months after the procedure
Secondary Clinical efficacy Comorbidity Follow-up 6: 24 months after the procedure
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