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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04808206
Other study ID # DM-PRO-ST2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date February 28, 2025

Study information

Verified date May 2023
Source Duomed
Contact Stephanie De Munter, PhD
Phone +32 (0)11 28 69 48
Email stephanie.de.munter@archerresearch.eu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this observational registry is to evaluate the safety and the clinical efficacy of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical). The goal of the study will be achieved by reporting peri- and postoperative complications and the clinical outcome after surgery in a prospectively maintained database.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date February 28, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers
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 the proposed follow-up visits. - Patient has a contra-indication for laparoscopic bariatric surgery.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium Ziekenhuis Oost-Limburg, campus St.-Jan Genk
Belgium Hôpital de Nivelles, groupe Jolimont Haine-Saint-Paul
Belgium Ziekenhuis Maas en Kempen Maaseik

Sponsors (1)

Lead Sponsor Collaborator
Duomed

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) Number of conversions, number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. At index procedure
Primary Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) Number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. At discharge up to 1 week
Primary Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) Number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. Follow-up 1: 1 month after the procedure
Primary Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) Number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. Follow-up 2: 6 months after the procedure
Primary Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) Number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. Follow-up 3: 12 months after the procedure
Primary Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) Number of re-interventions and number of participants with (serious) adverse events = grade II Clavien-Dindo. Follow-up 4: 24 months after the procedure
Secondary Device performance Number of procedures with technical success At index procedure
Secondary Device performance Scoring of: easy of intra-abdominal device positioning, grasping/climbing force, sharpness of the blades, staple-line formation, device stability, device maneuverability, device consistency and reliability, ergonomic design, hemostasis. Each of the aforementioned items receives a score from 0 to 4, with 0 indicating that the user is very unsatisfied and 4 indicating that the user is very satisfied. At index procedure
Secondary Clinical efficacy - weight loss Weight loss Follow-up 1: 1 month after the procedure
Secondary Clinical efficacy - weight loss Weight loss Follow-up 2: 6 months after the procedure
Secondary Clinical efficacy - weight loss Weight loss Follow-up 3: 12 months after the procedure
Secondary Clinical efficacy - weight loss Weight loss Follow-up 4: 24 months after the procedure
Secondary Number of participants with a post-operative change of cormorbidities Comorbidities (diabetes mellitus, peripheral arterial disease, coronary arterial disease, sleep disordered breathing, hypertension, dyslipidemia, hypercholesterolemia, hypertriglyceridemia, asthma, congestive heart failure, degenerative joint disease, gastroesophageal reflux, chronic obstructive pulmonary disease, use of immunosuppressants) 12 months after the surgical procedure as compared to the patients' comorbidities at baseline. Follow-up 3: 12 months after the procedure
Secondary Number of participants with a post-operative change of cormorbidities Comorbidities (diabetes mellitus, peripheral arterial disease, coronary arterial disease, sleep disordered breathing, hypertension, dyslipidemia, hypercholesterolemia, hypertriglyceridemia, asthma, congestive heart failure, degenerative joint disease, gastroesophageal reflux, chronic obstructive pulmonary disease, use of immunosuppressants) 24 months after the surgical procedure as compared to the patients' comorbidities at baseline. Follow-up 4: 24 months after the procedure
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