ObesitySTAP-JOLINCT04808206
A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
An observational study of Obesity and Roux-en-Y Gastric Bypass, run by Duomed at 3 sites in Belgium.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Roux-en-Y Gastric Bypass, Gastrostomy
- What is being tested?
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Jun 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Obese patients eligible for laparoscopic bariatric surgery. This registry will collect data from 250 laparoscopic bariatric procedures in which anastomoses are created with the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Ziekenhuis Oost-Limburg, campus St.-Jan
Genk
Hôpital de Nivelles, groupe Jolimont
Haine-Saint-Paul
Ziekenhuis Maas en Kempen
Maaseik
About this study
Official title: A Multicentric Prospective Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
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.
- Conditions
- Obesity, Roux-en-Y Gastric Bypass, Gastrostomy, Nissen Sleeve
- Being tested
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients eligible for laparoscopic bariatric surgery | Not described Receives: Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At index procedure
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.
Measured: At discharge up to 1 week
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.
Measured: Follow-up 1: 1 month after the procedure
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.
Measured: Follow-up 2: 6 months after the procedure
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.
Measured: Follow-up 3: 12 months after the procedure
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.
Measured: Follow-up 4: 24 months after the procedure
Secondary outcomes (8)
Device performance
Number of procedures with technical success
Measured: At index procedure
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.
Measured: At index procedure
Clinical efficacy - weight loss
Weight loss
Measured: Follow-up 1: 1 month after the procedure
Clinical efficacy - weight loss
Weight loss
Measured: Follow-up 2: 6 months after the procedure
Clinical efficacy - weight loss
Weight loss
Measured: Follow-up 3: 12 months after the procedure
Clinical efficacy - weight loss
Weight loss
Measured: Follow-up 4: 24 months after the procedure
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.
Measured: Follow-up 3: 12 months after the procedure
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.
Measured: Follow-up 4: 24 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jun 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salvatore Lobue, MD, Principal investigator, Hôpital de Nivelles (groupe Jolimont), Haine-Saint-Paul, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808206
- Sponsor's protocol ID
- DM-PRO-ST2021
- Acronym
- STAP-JOLI
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2021
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Prospective Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
- ClinicalTrials.gov ID
- NCT04808206
- Acronym / sponsor ID
- STAP-JOLI / DM-PRO-ST2021
- Conditions
- Obesity, Roux-en-Y Gastric Bypass, Gastrostomy, Nissen Sleeve
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- DuomedIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients eligible for laparoscopic bariatric surgery | – | Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Obese patients eligible for laparoscopic bariatric surgery. This registry will collect data from 250 laparoscopic bariatric procedures in which anastomoses are created with the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Obese patients eligible for laparoscopic bariatric surgery |
Primary outcome
Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)
Time frame: At index procedure
Number of conversions, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)
Time frame: At discharge up to 1 week
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)
Time frame: Follow-up 1: 1 month after the procedure
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)
Time frame: Follow-up 2: 6 months after the procedure
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)
Time frame: Follow-up 3: 12 months after the procedure
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)
Time frame: Follow-up 4: 24 months after the procedure
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
8 secondary outcomes
Device performance
Time frame: At index procedure
Device performance
Time frame: At index procedure
Clinical efficacy - weight loss
Time frame: Follow-up 1: 1 month after the procedure
Clinical efficacy - weight loss
Time frame: Follow-up 2: 6 months after the procedure
Clinical efficacy - weight loss
Time frame: Follow-up 3: 12 months after the procedure
Clinical efficacy - weight loss
Time frame: Follow-up 4: 24 months after the procedure
Number of participants with a post-operative change of cormorbidities
Time frame: Follow-up 3: 12 months after the procedure
Number of participants with a post-operative change of cormorbidities
Time frame: Follow-up 4: 24 months after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Lobue, MD principal investigator
Hôpital de Nivelles (groupe Jolimont), Haine-Saint-Paul, Belgium
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Roux-en-Y Gastric Bypass, run by Duomed at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical) (time frame: At index procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.