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Morbid ObesityEndosleeveNCT03554902

Endoscopic Gastric Tubulization

An observational study of Morbid Obesity, run by IHU Strasbourg at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Morbid Obesity
What is being tested?
Endoscopic gastric tubulization
Type of treatment
Surgery or procedure
How many people
300 participants
Where
1 siteFrance
Study dates
8 Jun 2018to Jun 2028
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients over 18 years old requiring a treatment for morbid obesity.

Who may be able to join

  • Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Silvana Perretta, MD, PhD contact

+ 33 3 69 55 05 31

silvana.perretta@ircad.fr

Michel Vix, MD contact

+ 33 3 69 55 13 03

michel.vix@chru-strasbourg.fr

France1 site, 1 recruiting

  • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

    Strasbourg, 67091

    Silvana Perretta, MD, PhD, + 33 3 69 55 05 31, silvana.perretta@ircad.fr

    Michel Vix, MD, +33 3 69 55 13 09, michel.vix@chru-strasbourg.fr

    Recruiting

Other trials in France

About this study

Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.

The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

Read the detailed description

Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Despite its advantages (long term weight loss, comorbidities related to obesity improvement…), bariatric surgery is risky. In fact, complications putting the patient into a life-threatening condition can occur. Endoscopic approaches are similar to current surgical methods but less invasive, safer and allow ambulatory care.

Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This leads to similar results (gastric restriction, weight loss, quality of life and comorbidities improvement) compared with standard surgical procedure while reducing the risk of complications.

One of the major benefit of this technique is its reversibility. A new surgical or endoscopic procedure is possible at a later stage.

Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.

The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

Conditions
Morbid Obesity
Being tested
Endoscopic gastric tubulization
Keywords
Endoscopic gastric tubulization, Weight loss, Quality of life
Medical subject headings
Obesity, Morbid, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic gastric tubulizationProcedure or surgery

    Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).

Study groups in NCT03554902
Study groupRoleWhat they receive
Endoscopic gastric tubulizationEndoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).
Receives: Procedure: Endoscopic gastric tubulization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in weight loss

    Change in weight loss measured in kilograms.

    Measured: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

  2. Change in excess weight loss

    Change in excess weight loss measured in percentage. Excess weight loss = (weight loss at time point / weight loss goal to reach a body mass index of 25 kg/m²) x 100

    Measured: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

  3. Change in body mass index variation

    Change in body mass index variation measured in kg/m².

    Measured: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

Secondary outcomes (9)

  1. Number of patients with procedure-related adverse event

    Number of patients with procedure-related adverse event within 12 months after procedure.

    Measured: 7 days, 1 - 3 - 6 - 9 and 12 months after procedure

  2. Comorbidities improvement

    Improvement of sleep apnea, arterial hypertension, diabetes, reflux, osteoarticular disorders compared with preoperative data.

    Measured: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

  3. Quality of life improvement

    Improvement of quality of life assessed by Moorehead-Ardelt Quality of Life questionnaire II. Score range from -3.0 to 3.0.

    • Score from -3.0 to -2.1: very poor quality of life
    • Score from -2.0 to -1.1: poor quality of life
    • Score from -1.0 to 1.0: fair quality of life
    • Score from 1.1 to 2.0: good quality of life
    • Score from 2.1 to 3.0: very good quality of life.

    Measured: 3 - 12 - 18 and 24 months after procedure

  4. Gastro-intestinal quality of life improvement

    Improvement of quality of life assessed by the Gastro-Intestinal Quality of Life Index questionnaire. A global score > 125 is considered as normal.

    Measured: 3 - 12 - 18 and 24 months after procedure

  5. Modification in the feeling of satiety

    Satiety assessed by Three Factors Eating Questionnaire - R18. Three dimensions are assessed. The higher the score is, the more important the dimension is.

    • Restrained eating: score from 6 to 24
    • Uncontrolled eating: score from 9 to 36
    • Emotional eating: score from 3 to 12.

    Measured: 1 - 3 - 6 - 12 - 18 and 24 months after procedure

  6. Upper GI tract radiologic evaluation

    Upper GI control series.

    Measured: 1 day, 6 - 12 and 24 months after procedure

  7. Upper GI tract endoscopic evaluation

    Upper GI control gastroscopy.

    Measured: 6 - 12 and 24 months after procedure

  8. Procedure duration

    Time required to perform the endoscopic gastric tubulization.

    Measured: At time of procedure

  9. Number of stitches in place

    Number of stitches put in place during the endoscopic gastric tubulization.

    Measured: At time of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2018
  2. Study start8 Jun 2018
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03554902
Sponsor's protocol ID
16-001-OBS (CPP)
Other IDs
2017-A03599-44
Acronym
Endosleeve
Status last verified
Apr 2025
First submitted
16 May 2018
Last updated
1 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lopez-Nava G, Galvao MP, da Bautista-Castano I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy. 2015 May;47(5):449-52. doi: 10.1055/s-0034-1390766. Epub 2014 Nov 7.

    PubMed 25380508

  • Lopez-Nava G, Galvao MP, Bautista-Castano I, Jimenez-Banos A, Fernandez-Corbelle JP. Endoscopic Sleeve Gastroplasty: How I Do It? Obes Surg. 2015 Aug;25(8):1534-8. doi: 10.1007/s11695-015-1714-7.

    PubMed 26003549

  • Lopez-Nava G, Galvao M, Bautista-Castano I, Fernandez-Corbelle JP, Trell M. Endoscopic sleeve gastroplasty with 1-year follow-up: factors predictive of success. Endosc Int Open. 2016 Feb;4(2):E222-7. doi: 10.1055/s-0041-110771. Epub 2016 Jan 15.

    PubMed 26878054

  • Sharaiha RZ, Kedia P, Kumta N, DeFilippis EM, Gaidhane M, Shukla A, Aronne LJ, Kahaleh M. Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy. 2015 Feb;47(2):164-6. doi: 10.1055/s-0034-1390773. Epub 2014 Nov 7.

    PubMed 25380510

  • Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.

    PubMed 23711556

Questions about this trial

What is this clinical trial studying?

An observational study of Morbid Obesity, run by IHU Strasbourg 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 1 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 1 May 2025. 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?

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?

Contact Silvana Perretta, MD, PhD (+ 33 3 69 55 05 31, silvana.perretta@ircad.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weight loss (time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03554902, which also lists 5 linked publications.

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 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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