Weight LossEndominaNCT02582229
A Prospective Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction.
A study testing Endomina in people with Weight Loss, run by Erasme University Hospital at 3 sites in 3 countries.
Trial summary
Surgery is 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). Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Endomina
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2015to Jul 2016
- 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 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 21-64 years;
- 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.
Who cannot join
- Achalasia and any other esophageal motility disorders
- 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 month
- Severe renal, hepatic, pulmonary disease or cancer;
- GI stenosis or obstruction
- Pregnancy or breastfeeding
- Impending gastric surgery 60 days post intervention;
- Currently participating in other study
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Czechia1 site
Internal cilic - department of Gastroenterology - University Hospital
Ostrava, 70800
About this study
Surgery is 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 later 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 (1,2).
Read more
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 (3,4).
A transoral or endoluminal approach (ie, 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 (5).
Read the detailed description
Endomina (Endo Tools Therapeutics, Nivelles, Belgium) is CE mark robot driven device that may be attached to an endoscope inside the body and allows remote manipulation of the arms of devices during a peroral intervention. It offers the possibilities of making transoral surgical full thickness sutures and may allow performing, via a transoral route.
After a first trial on pigs (safety) we did a second trial on human. This trial included 11 patients treated with the same technique. There were no complications and the short term results were encouraging.
Study design:
Prospective, non-randomized, interventional, open-label, multi-center efficacy study.
Objectives:
Study to evaluate the efficacy of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device. In the literature the efficacy of an endoluminal technique is defined as a loss of weight of 25% excess weight loss (EWL) sustained at 1 year (6).
Endpoints Secondary endpoint: Efficacy Information on efficacy will be obtained by measurements of total weight loss and excess weight loss during 12 months Secondary endpoint: Safety 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.
In addition, safety assessments will be determined based on physical examination (vital signs) and laboratory tests during scheduled visits. Safety evaluations will also be performed to ensure no subsequent adverse events have occurred and to ensure any adverse events during the trial that are considered on-going are stable or have resolved. Safety will be assessed at 1, 3, 6 and 12 months following the intervention.
Sample size •40 patients will be enrolled Based on the result of our previous study, with a beta power of 80% and an alpha error of 5%, the number of patient needed to detect a 25% EWL reduction at one year is 34. Considering a lost to follow-up of 10%, 40 patients is required.
Study duration:
•6 months of enrolment and 12 months of follow up Overall design This will be a prospective, non-randomized, open-label, multi-center, interventional, efficacy study.
A period of approximately 6 months is anticipated form the time the first patient is enrolled to the completion of the last patient. There will be no randomization in this study.
Once baseline eligibility criteria have been met all patients will undergo the same treatment protocol. A subject will be considered "enrolled" if he/she has signed the informed consent, passed all screening criteria and has undergone a procedure.
Criteria for discontinuation If a subject discontinues participation in the study, he or she will be contacted in order to obtain information about the reason(s) for discontinuation and collection of any potential AEs. The Investigator will document the reason for Subject Withdrawal on the Patient Case Report Form (CRF). Discontinued patients will be followed until all AEs resolve or until the Investigator decides that follow-up are no longer necessary.
Study Design:
Devices used during the protocol In addition to Endomina device (provided as companionate by Endotools Options) any other required endoscopic accessories can be used during the procedure.
Point of enrollment A subject will be considered "enrolled" if he/she has signed the informed consent, passed all screening criteria and has agreed to the procedure.
Study duration and number of subjects A period of approximately 6 months is anticipated form the time the time the first patient is enrolled to the completion of the last patient.
Lab tests and other screening procedures can occur as early as 30 days prior to scheduled procedure.
The participants will be followed as follow:
- Day (-1): Admission
- Day (0): Procedure
- Day (+1): Clinical Follow up and discharge (i.e. if no adverse effects observed)
- 1 month: Clinical assessment
- 3 month: Follow up endoscopy, Clinical assessment
- 6 month: Clinical assessment
- 12 month: Clinical and endoscopic assessment On Parallel a nutritional specialist will monitor the patient on quarterly basis (1,3,6,12).
Study procedures The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure.
- Conditions
- Weight Loss
- Being tested
- Endomina
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndominaDevice
The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Interventionnal | Experimental | The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure. Receives: Device: Endomina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Weight loss - Excess Weight Loss - BMI
Measured: one year
Secondary outcomes (1)
Complications
Vital signs - Pain - Bleeding - Perforation - other
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Deviere, MD,PhD, Study director, Hopital Erasme, Gastroenterology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582229
- Sponsor's protocol ID
- P2015/432
- Acronym
- Endomina
- Status last verified
- Sep 2016
- First submitted
- 16 Oct 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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 15479938Magro 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 18392907Fogel 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 18355825Paxton 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 15760496Huberty V, Machytka E, Boskoski I, Barea M, Costamagna G, Deviere J. Endoscopic gastric reduction with an endoluminal suturing device: a multicenter prospective trial with 1-year follow-up. Endoscopy. 2018 Dec;50(12):1156-1162. doi: 10.1055/a-0630-1224. Epub 2018 Jun 15.
PubMed 29906810
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction.
- ClinicalTrials.gov ID
- NCT02582229
- Acronym / sponsor ID
- Endomina / P2015/432
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 Oct 2015 (estimated)
- 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.
Surgery is 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 later 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 (1,2).
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 (3,4).
A transoral or endoluminal approach (ie, 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 (5).
Detailed description
Endomina (Endo Tools Therapeutics, Nivelles, Belgium) is CE mark robot driven device that may be attached to an endoscope inside the body and allows remote manipulation of the arms of devices during a peroral intervention. It offers the possibilities of making transoral surgical full thickness sutures and may allow performing, via a transoral route.
After a first trial on pigs (safety) we did a second trial on human. This trial included 11 patients treated with the same technique. There were no complications and the short term results were encouraging.
Study design:
Prospective, non-randomized, interventional, open-label, multi-center efficacy study.
Objectives:
Study to evaluate the efficacy of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device. In the literature the efficacy of an endoluminal technique is defined as a loss of weight of 25% excess weight loss (EWL) sustained at 1 year (6).
Endpoints Secondary endpoint: Efficacy Information on efficacy will be obtained by measurements of total weight loss and excess weight loss during 12 months Secondary endpoint: Safety 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.
In addition, safety assessments will be determined based on physical examination (vital signs) and laboratory tests during scheduled visits. Safety evaluations will also be performed to ensure no subsequent adverse events have occurred and to ensure any adverse events during the trial that are considered on-going are stable or have resolved. Safety will be assessed at 1, 3, 6 and 12 months following the intervention.
Sample size •40 patients will be enrolled Based on the result of our previous study, with a beta power of 80% and an alpha error of 5%, the number of patient needed to detect a 25% EWL reduction at one year is 34. Considering a lost to follow-up of 10%, 40 patients is required.
Study duration:
•6 months of enrolment and 12 months of follow up Overall design This will be a prospective, non-randomized, open-label, multi-center, interventional, efficacy study.
A period of approximately 6 months is anticipated form the time the first patient is enrolled to the completion of the last patient. There will be no randomization in this study.
Once baseline eligibility criteria have been met all patients will undergo the same treatment protocol. A subject will be considered "enrolled" if he/she has signed the informed consent, passed all screening criteria and has undergone a procedure.
Criteria for discontinuation If a subject discontinues participation in the study, he or she will be contacted in order to obtain information about the reason(s) for discontinuation and collection of any potential AEs. The Investigator will document the reason for Subject Withdrawal on the Patient Case Report Form (CRF). Discontinued patients will be followed until all AEs resolve or until the Investigator decides that follow-up are no longer necessary.
Study Design:
Devices used during the protocol In addition to Endomina device (provided as companionate by Endotools Options) any other required endoscopic accessories can be used during the procedure.
Point of enrollment A subject will be considered "enrolled" if he/she has signed the informed consent, passed all screening criteria and has agreed to the procedure.
Study duration and number of subjects A period of approximately 6 months is anticipated form the time the time the first patient is enrolled to the completion of the last patient.
Lab tests and other screening procedures can occur as early as 30 days prior to scheduled procedure.
The participants will be followed as follow:
- Day (-1): Admission
- Day (0): Procedure
- Day (+1): Clinical Follow up and discharge (i.e. if no adverse effects observed)
- 1 month: Clinical assessment
- 3 month: Follow up endoscopy, Clinical assessment
- 6 month: Clinical assessment
- 12 month: Clinical and endoscopic assessment On Parallel a nutritional specialist will monitor the patient on quarterly basis (1,3,6,12).
Study procedures The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventionnal | Experimental | Device: EndominaThe intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 21-64 years;
- 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.
Key exclusion criteria (8 listed)
- Achalasia and any other esophageal motility disorders
- 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 month
- Severe renal, hepatic, pulmonary disease or cancer;
- GI stenosis or obstruction
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 |
|---|---|---|
| EndominaThe intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure. | Device | Interventionnal |
Primary outcome
Weight Loss
Time frame: one year
Weight loss - Excess Weight Loss - BMI
1 secondary outcome
Complications
Time frame: one year
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 13 Sep 2016.
- Results publication: PubMed 15479938Buchwald 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.
- Results publication: PubMed 18392907Magro 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.
- Results publication: PubMed 18355825Fogel 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.
- Results publication: PubMed 15760496Paxton 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.
- Derived from this study: PubMed 29906810Huberty V, Machytka E, Boskoski I, Barea M, Costamagna G, Deviere J. Endoscopic gastric reduction with an endoluminal suturing device: a multicenter prospective trial with 1-year follow-up. Endoscopy. 2018 Dec;50(12):1156-1162. doi: 10.1055/a-0630-1224. Epub 2018 Jun 15.
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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.
Jacques Deviere, MD,PhD study director
Hopital Erasme, Gastroenterology Department
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endomina in people with Weight Loss, run by Erasme University Hospital at 3 sites in 3 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 4 inclusion and 8 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 13 Sep 2016. 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, Czechia, Italy. 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?
Weight Loss (time frame: one year). 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 NCT02582229, 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 13 Sep 2016.