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ObesityNCT03255005

Endomina Controlled Study

A study testing Endomina and Diet in people with Obesity, run by Erasme University Hospital at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this trial is to evaluate the efficacy of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device. Safety will also be characterized, in particular by the incidence of all Adverse Device Effects (ADEs). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
Endomina and Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesin 2 countries
Study dates
5 Sep 2017to 26 Mar 2020
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18-65 years;
  • Class I or class II obesity (i.e. BMI between 30 to 40 kg/m²);
  • Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations;
  • Must be able to understand and be willing to provide written informed consent;
  • Must live within 75 km of the treatment site;
  • Had followed the bariatric multidisciplinary workup (blood analyses, dietician, psychologist and doctor appointments).

Who cannot join

  • Achalasia and any other esophageal motility disorders;
  • Severe esophagitis;
  • Gastro-duodenal ulcer;
  • Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
  • Hypertension: uncontrolled hypertension during last 3 months;
  • Diabetes: uncontrolled diabetes (on insulin therapy or oral therapy with Hba1c > 10%);
Show all 14Show fewer
  • TBWL >5% over the last 6 months;
  • Severe renal, hepatic, pulmonary disease or cancer;
  • GI stenosis or obstruction;
  • Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
  • Previous bariatric surgery, balloon or other endoscopic obesity-related therapy;
  • Anticoagulant therapy;
  • Impending gastric surgery 60 days post intervention;
  • Currently participating in other study

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site

  • Gastroenterology Department Erasme Hospital

    Brussels, 1070

Other trials in Belgium

France1 site

  • APHM Hopital Marseille Nord Hepato-Gastroentérologie et Oncologie Digestive

    Marseille, 13915

Other trials in France

About this study

Official title: A Controlled Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) as an Aid for Endoscopic Gastric Reduction

The aim of this trial is to evaluate the efficacy of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device. Safety will also be characterized, in particular by the incidence of all Adverse Device Effects (ADEs). A secondary endpoint is to compare a delayed treatment control group (diet alone; crossover at 6 months) with a treatment group (EVG plus diet). Other secondary endpoints include improvements in other obesity measures.

Read the detailed description

Surgery is currently the only effective treatment for morbid obesity and can be divided into restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary pancreatic deviation and duodenal switch) or a combination of both (RYGBP).

This latter technique is the most common and most effective surgical procedure performed worldwide and has been processed to be an effective treatment of morbid obesity and its complications, achieving excess weight loss of 65 to 80 %; 1-2 years after surgery.

Vertical gastric plication is a novel surgical approach for reducing the stomach capacity. Anterior surface plication and greater curvature plication are variations of vertical gastric plication that reduce the gastric capacity through infolding of the anterior surface or greater curvature of the stomach, respectively. These approaches have been tested, with positive results.

A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers the potential for additional benefit to the patient, because the procedures continue to become more and more minimally invasive.

Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery and might become part of the armamentarium of obesity management.

Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that may be attached to an endoscope inside the body and allows remote actuation of the device during a peroral intervention. It offers the possibilities of making transoral full thickness tissue apposition and may allow performing, via a transoral route, large plications with tight serosa to serosa apposition.

After a first trial on pigs (safety), a second trial on human patients was performed. This trial included 11 patients treated with the same technique. There were no complications and the short term results were encouraging with 41% EWL at 6 month.

A multicentric trial NCT02582229 entitled: " A Prospective Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction. " is ongoing and inclusion of patients ended in December 2016 with a total of 51 patients included in 3 European centers. Early results of the trial had showed that dietician follow-up is an important part of the success. During that time implementation of the procedure had been done.

The aim of this trial is to compare a control group (diet alone) with a treatment group (Endomina procedure plus diet).

Conditions
Obesity
Being tested
Endomina, Diet
Keywords
obesity, endoscopy, endoscopic sleeve gastroplasty
Medical subject headings
Obesity

What participants receive

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

  • EndominaDevice

    Endoscopic sleeve reduction

  • DietBehavioural

    Multidisciplinary follow-up

Study groups in NCT03255005
Study groupRoleWhat they receive
Treatment groupActive comparatorEndoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year
Receives: Device: Endomina
Controled groupActive comparatorDiet for 6 months then Endoscopic sleeve gastroplasty (Endomina) with multidisciplinary follow-up for 1 year
Receives: Device: Endomina; Behavioral: Diet

What is being measured

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

  1. Incidence of all Adverse Device Effects

    Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.

    Measured: one year from procedure

  2. Weight loss

    total weight loss and excess weight loss

    Measured: one year from procedure

Secondary outcomes (5)

  1. Weight loss at 6 months

    comparison between diet and treatment group at 6 months

    Measured: at 6 months after the procedure (treatment group)

  2. More than 15% weight loss

    Proportion of patients in the Endomina Group with a loss of weight of more than 15%

    Measured: one year from procedure

  3. Quality of life

    SF36

    Measured: one year from procedure

  4. TBWL

    Mean % total body weight loss (%TBWL)

    Measured: one year from procedure

  5. Weight and height

    To calculate the body mass index (BMI)

    Measured: one year from procedure

Timeline

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

  1. First posted21 Aug 2017
  2. Study start5 Sep 2017
  3. Primary completion26 Mar 2020
  4. Study completion26 Mar 2020

Resources

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
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Group A: treatment J0 + Diet 1 year Group B: Diet 6 months - Treatment - Diet 1 year
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03255005
Sponsor's protocol ID
P2017/401
Status last verified
May 2020
First submitted
8 Aug 2017
Last updated
20 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee; Abu Dayyeh BK, Kumar N, Edmundowicz SA, Jonnalagadda S, Larsen M, Sullivan S, Thompson CC, Banerjee S. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc. 2015 Sep;82(3):425-38.e5. doi: 10.1016/j.gie.2015.03.1964. Epub 2015 Jul 29.

    PubMed 26232362

  • Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008 Jun;18(6):648-51. doi: 10.1007/s11695-007-9265-1. Epub 2008 Apr 8.

    PubMed 18392907

  • Menchaca HJ, Harris JL, Thompson SE, Mootoo M, Michalek VN, Buchwald H. Gastric plication: preclinical study of durability of serosa-to-serosa apposition. Surg Obes Relat Dis. 2011 Jan-Feb;7(1):8-14. doi: 10.1016/j.soard.2010.11.002. Epub 2010 Nov 12.

    PubMed 21255733

  • Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51-8. doi: 10.1016/j.gie.2007.10.061. Epub 2008 Mar 19.

    PubMed 18355825

  • Paxton JH, Matthews JB. The cost effectiveness of laparoscopic versus open gastric bypass surgery. Obes Surg. 2005 Jan;15(1):24-34. doi: 10.1381/0960892052993477.

    PubMed 15760496

  • Huberty V, Ibrahim M, Hiernaux M, Chau A, Dugardeyn S, Deviere J. Safety and feasibility of an endoluminal-suturing device for endoscopic gastric reduction (with video). Gastrointest Endosc. 2017 Apr;85(4):833-837. doi: 10.1016/j.gie.2016.08.007. Epub 2016 Aug 22.

    PubMed 27562938

  • ASGE Bariatric Endoscopy Task Force; ASGE Technology Committee; Abu Dayyeh BK, Edmundowicz SA, Jonnalagadda S, Kumar N, Larsen M, Sullivan S, Thompson CC, Banerjee S. Endoscopic bariatric therapies. Gastrointest Endosc. 2015 May;81(5):1073-86. doi: 10.1016/j.gie.2015.02.023. Epub 2015 Mar 28. No abstract available.

    PubMed 25828245

  • ASGE/ASMBS Task Force on Endoscopic Bariatric Therapy; Ginsberg GG, Chand B, Cote GA, Dallal RM, Edmundowicz SA, Nguyen NT, Pryor A, Thompson CC. A pathway to endoscopic bariatric therapies. Gastrointest Endosc. 2011 Nov;74(5):943-53. doi: 10.1016/j.gie.2011.08.053. No abstract available.

    PubMed 22032311

  • Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.

    PubMed 15479938

  • Huberty V, Boskoski I, Bove V, Van Ouytsel P, Costamagna G, Barthet MA, Deviere J. Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial. Gut. 2020 Oct 28:gutjnl-2020-322026. doi: 10.1136/gutjnl-2020-322026. Online ahead of print.

    PubMed 33115727

Questions about this trial

What is this clinical trial studying?

A study testing Endomina and Diet in people with Obesity, run by Erasme University Hospital at 2 sites in 2 countries.

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 6 inclusion and 14 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 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, 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?

Incidence of all Adverse Device Effects (time frame: one year from procedure). 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?

On the ClinicalTrials.gov record for NCT03255005, which also lists 10 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 20 May 2020.

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