ObesityNCT02534662
Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) for Gastric Reduction
A study testing ENDOMINA in people with Obesity, run by Theodor Bilharz Research Institute at 1 site in Belgium.
Trial summary
Objectives: Study to evaluate safety and feasibility of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device. Briefly, Vertical gastric plication is a novel surgical approach for reducing the stomach capacity. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- ENDOMINA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- May 2015to Jun 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 > 40 Kg/m2 or BMI >35 Kg/m2 with comorbidities
- 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;
- GIT stenosis or obstruction
- Pregnancy or breastfeeding
- Impending gastric surgery 60 days post intervention;
- Currently participating in other study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction
Objectives: Study to evaluate safety and feasibility of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device.
Briefly, 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.
Read more
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.
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.
The participants will be followed as follow:
Day (0): Procedure Day (+1): Clinical Follow up and discharge (i.e. if no adverse effects observed)
1 month: Follow up endoscopy, Clinical assessment 3 month: Follow up endoscopy, Clinical assessment 6 month: Final assessment (Endoscopically and Clinical) 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.
Read the detailed description
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 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 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. 4
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.
Study design Prospective, non-randomized, open-label, single-center safety and feasibility study
Objectives:
Study to evaluate safety and feasibility of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device.
- Conditions
- Obesity
- Being tested
- ENDOMINA
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDOMINADevice
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 |
|---|---|---|
| Treatment Arm | Experimental | 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.
Safety characterized by the incidence of all Adverse Device Effects (ADEs), physical examination (vital signs), laboratory tests, and subsequent adverse events
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 and 6 month following the intervention.
Measured: 12 month
Secondary outcomes (1)
Feasibility assessment obtained by measurements of total weight loss and excess weight loss
Information on efficacy will be obtained by measurements of total weight loss and excess weight loss during 6 month with an optional extension at 12 month
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ibrahim, Theodor Bilharz Research Institute
- Investigators
- Jacques Deviere, PHD, Study chair, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534662
- Sponsor's protocol ID
- ENDOMINA
- Status last verified
- Apr 2021
- First submitted
- 25 Aug 2015
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction
- ClinicalTrials.gov ID
- NCT02534662
- Acronym / sponsor ID
- ENDOMINA
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Aug 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.
Objectives: Study to evaluate safety and feasibility of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device.
Briefly, 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 (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.
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.
The participants will be followed as follow:
Day (0): Procedure Day (+1): Clinical Follow up and discharge (i.e. if no adverse effects observed)
1 month: Follow up endoscopy, Clinical assessment 3 month: Follow up endoscopy, Clinical assessment 6 month: Final assessment (Endoscopically and Clinical) 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.
Detailed description
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 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 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. 4
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.
Study design Prospective, non-randomized, open-label, single-center safety and feasibility study
Objectives:
Study to evaluate safety and feasibility of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: ENDOMINAEndomina 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 > 40 Kg/m2 or BMI >35 Kg/m2 with comorbidities
- 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;
- GIT 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 |
|---|---|---|
| ENDOMINAEndomina 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 | Treatment Arm |
Primary outcome
Safety characterized by the incidence of all Adverse Device Effects (ADEs), physical examination (vital signs), laboratory tests, and subsequent adverse events
Time frame: 12 month
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 and 6 month following the intervention.
1 secondary outcome
Feasibility assessment obtained by measurements of total weight loss and excess weight loss
Time frame: 12 month
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 27 Apr 2021.
- Derived from this study: PubMed 27562938Huberty 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.
- Individual participant dataSharing planned: Yes
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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, PHD study chair
Université Libre de Bruxelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDOMINA in people with Obesity, run by Theodor Bilharz Research Institute at 1 site 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 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 27 Apr 2021. 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 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?
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?
Safety characterized by the incidence of all Adverse Device Effects (ADEs), physical examination (vital signs), laboratory tests, and subsequent adverse events (time frame: 12 month). 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 NCT02534662, which also lists 1 linked publication.
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 27 Apr 2021.