ObesitySLEEVENCT05072067
EFFICACY OF THE SLEEVE GASTROPLASTY WITH THE ENDOSCOPIC SYSTEM OVERSTICH SX ON WEIGHT LOSS AND REDUCTION OF CO-MORBIDITY FOR OBESE PATIENTS
A study testing the sleeve gastroplasty with the endoscopic system Overstich SX in people with Obesity, run by Clinique du Trocadéro at 1 site in France.
Trial summary
The OverStitch ™ Sx System (Apollo Endosurgery Inc., Austin, Tx, Usa) is a new generation of endoscopic suturing device. It is inserted into an endoscope allowing the approximation of Luc Karsentys soft tissue by placement of sutures. It is as effective a suture system as a surgical system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- the sleeve gastroplasty with the endoscopic system Overstich SX
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2021to 26 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18, male or female
- Patient with obesity with a BMI> 30 or BMI> 40 (if surgery contraindicated or refused by the patient)
- Patient with a weight gain after sleeve gastroplasty or sleeve gastrectomy
- Informed and written consent of the patient obtained
- Complete clinical examination
- Lack of participation in another clinical study
- Patient able to follow, understand the study and answer the questionnaire
Who cannot join
- Haemorrhagic disease, haemostasis and coagulation disorder and platelets <60000 / mm3).
- Breastfeeding women
- Toxicomany, alcoolism
- Patient known for gastric lesion requiring surveillance or familial history of gastric neoplasia
- Hiatus hernia> 4 cm high
Trial locations and contacts
1 site in 1 country.
About this study
The OverStitch ™ Sx System (Apollo Endosurgery Inc., Austin, Tx, Usa) is a new generation of endoscopic suturing device. It is inserted into an endoscope allowing the approximation of Luc Karsentys soft tissue by placement of sutures. It is as effective a suture system as a surgical system. The OverStitch ™ Sx allows suturing in the upper and lower GI with a flexible single channel endoscope. Previously, the ™ Overstich was only compatible with an Olympus dual channel endoscope.
Thus, a wide range of interventions are possible, including gastric endoplastic sleeve (ESG), RYGB revision, anastomotic fistula repair and / or sleeve revision. In each of these indications, the OverStitch (OverStitch) ™ system has shown its effectiveness and safety.
Read more
The OverStitch Endoscopic ™ Suture System allows the entire digestive wall to be sutured through a flexible endoscope. Thus, a wide range of interventions are possible, including gastric pocket repair after gastric bypass surgery, anastomotic fistula repair, endoscopic treatment of digestive perforation, and endoscopic sleeve surgery. In each of these indications, the OverStitch system has demonstrated its effectiveness and safety. But this technique is recent, especially in France. In addition, no data has yet been released regarding the new Overstitch ™ Sx device compatible with all single channel endoscopes.
An observational study including patients in French centers that are experts in therapeutic endoscopy seems essential to us to better assess this new device and this new technique in practice
- Conditions
- Obesity
- Being tested
- the sleeve gastroplasty with the endoscopic system Overstich SX
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the sleeve gastroplasty with the endoscopic system Overstich SXProcedure or surgery
the sleeve gastroplasty with the endoscopic system Overstich SX
| Study group | Role | What they receive |
|---|---|---|
| OBESE PATIENT | Experimental | OverStitch™ Sx with a Single channel endoscop CO2 Insufflation, patient on decubitus dorsal, with intubate 3 to 7 sutures, from the antral ogiv to the cardia are done Receives: Procedure: the sleeve gastroplasty with the endoscopic system Overstich SX |
What is being measured
The primary outcome is the main question the study is designed to answer.
For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost
Measured: 6 MONTHS
For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost
Measured: 12 MONTHS
Secondary outcomes (3)
Evaluation of safety Immediate morbidity
Measured: DAY 1
For sleeve revision, by the rate of patients with a percentage of total weight lost
Measured: 6 MONTHS
For sleeve revision, by the rate of patients with a percentage of total weight lost
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start14 Oct 2021
- Primary completion30 Jun 2023
- Study completion26 Sep 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique du Trocadéro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072067
- Sponsor's protocol ID
- 2021-A01562-39
- Acronym
- SLEEVE
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2021
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF THE SLEEVE GASTROPLASTY WITH THE ENDOSCOPIC SYSTEM OVERSTICH SX ON WEIGHT LOSS AND REDUCTION OF CO-MORBIDITY FOR OBESE PATIENTS
- ClinicalTrials.gov ID
- NCT05072067
- Acronym / sponsor ID
- SLEEVE / 2021-A01562-39
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Clinique du TrocadéroUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 8 Oct 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 OverStitch ™ Sx System (Apollo Endosurgery Inc., Austin, Tx, Usa) is a new generation of endoscopic suturing device. It is inserted into an endoscope allowing the approximation of Luc Karsentys soft tissue by placement of sutures. It is as effective a suture system as a surgical system. The OverStitch ™ Sx allows suturing in the upper and lower GI with a flexible single channel endoscope. Previously, the ™ Overstich was only compatible with an Olympus dual channel endoscope.
Thus, a wide range of interventions are possible, including gastric endoplastic sleeve (ESG), RYGB revision, anastomotic fistula repair and / or sleeve revision. In each of these indications, the OverStitch (OverStitch) ™ system has shown its effectiveness and safety.
The OverStitch Endoscopic ™ Suture System allows the entire digestive wall to be sutured through a flexible endoscope. Thus, a wide range of interventions are possible, including gastric pocket repair after gastric bypass surgery, anastomotic fistula repair, endoscopic treatment of digestive perforation, and endoscopic sleeve surgery. In each of these indications, the OverStitch system has demonstrated its effectiveness and safety. But this technique is recent, especially in France. In addition, no data has yet been released regarding the new Overstitch ™ Sx device compatible with all single channel endoscopes.
An observational study including patients in French centers that are experts in therapeutic endoscopy seems essential to us to better assess this new device and this new technique in practice
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OBESE PATIENT | Experimental | Procedure: the sleeve gastroplasty with the endoscopic system Overstich SXOverStitch™ Sx with a Single channel endoscop CO2 Insufflation, patient on decubitus dorsal, with intubate 3 to 7 sutures, from the antral ogiv to the cardia are done |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient over 18, male or female
- Patient with obesity with a BMI> 30 or BMI> 40 (if surgery contraindicated or refused by the patient)
- Patient with a weight gain after sleeve gastroplasty or sleeve gastrectomy
- Informed and written consent of the patient obtained
- Complete clinical examination
Key exclusion criteria (5 listed)
- Haemorrhagic disease, haemostasis and coagulation disorder and platelets <60000 / mm3).
- Breastfeeding women
- Toxicomany, alcoolism
- Patient known for gastric lesion requiring surveillance or familial history of gastric neoplasia
- Hiatus hernia> 4 cm high
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 |
|---|---|---|
| the sleeve gastroplasty with the endoscopic system Overstich SXthe sleeve gastroplasty with the endoscopic system Overstich SX | Procedure or surgery | OBESE PATIENT |
Primary outcome
For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost
Time frame: 6 MONTHS
For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost
Time frame: 12 MONTHS
3 secondary outcomes
Evaluation of safety Immediate morbidity
Time frame: DAY 1
For sleeve revision, by the rate of patients with a percentage of total weight lost
Time frame: 6 MONTHS
For sleeve revision, by the rate of patients with a percentage of total weight lost
Time frame: 12 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the sleeve gastroplasty with the endoscopic system Overstich SX in people with Obesity, run by Clinique du Trocadéro at 1 site in France.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost (time frame: 6 MONTHS). The study lists 2 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 28 Sep 2023.