Bariatric SurgeryEndominaNCT03608267
Safety and Feasibility of Endomina, an Candy Cane Syndrome Endoluminal Suturing Device
A study testing Endomina in people with Bariatric Surgery and Complication, run by Erasme University Hospital at 2 sites in Belgium.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery, Complication
- What is being tested?
- Endomina
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesBelgium
- Study dates
- 6 Mar 2018to 3 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
- Proven Candy cane syndrome by barium swallow
- Age between 18-65 years;
- 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;
- Severe renal, hepatic, pulmonary disease or cancer;
- GI stenosis or obstruction;
- Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
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- Anticoagulant therapy;
- Impending gastric surgery 60 days post intervention;
- Currently participating in other study
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
CUB Hopital erasme
Anderlecht, 1070
Gastroenterology Department Erasme Hospital
Brussels, 1070
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 Afferent Loop Syndrome
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 (1,2).
Read more
Morbidity after RYGB includes the candy cane syndrome or afferent loop syndrome. Candy cane Roux syndrome in patients who have undergone RYGB refers to an excessively long blind afferent Roux limb at the gastrojejunostomy causing postprandial pain often relieved by vomiting. It is believed that the blind afferent limb ("candy cane") acts as an obstructed loop when filled with food (often preferentially), and the distention of the loop causes pain until the food either spills into the Roux limb or is vomited back out (3).
Patients have been reported presenting as early as three months and as late as 11 years after their initial RYGB, typically with symptoms of postprandial epigastric pain, nausea, vomiting, and reflux or food regurgitation (4). The diagnosis is confirmed by upper gastrointestinal contrast studies or endoscopy. On upper gastrointestinal series, the afferent limb fills before contrast spills into the Roux limb. On upper endoscopy, the afferent limb is usually the most direct outlet of the gastrojejunostomy (3).
The treatment is revision bariatric surgery, most commonly laparoscopic resection of the afferent limb, which ranged in length from 3 to 22 cm in one study (mean of 7.6 cm) (3). Symptoms resolve after revision surgery in most patients. Surgeons should minimize the length of the blind afferent loop left at the time of initial RYGB to prevent candy cane Roux syndrome.
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.
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 (1,2).
Morbidity after RYGB includes the candy cane syndrome or afferent loop syndrome. Candy cane Roux syndrome in patients who have undergone RYGB refers to an excessively long blind afferent Roux limb at the gastrojejunostomy causing postprandial pain often relieved by vomiting. It is believed that the blind afferent limb ("candy cane") acts as an obstructed loop when filled with food (often preferentially), and the distention of the loop causes pain until the food either spills into the Roux limb or is vomited back out (3).
Patients have been reported presenting as early as three months and as late as 11 years after their initial RYGB, typically with symptoms of postprandial epigastric pain, nausea, vomiting, and reflux or food regurgitation (4). The diagnosis is confirmed by upper gastrointestinal contrast studies or endoscopy. On upper gastrointestinal series, the afferent limb fills before contrast spills into the Roux limb. On upper endoscopy, the afferent limb is usually the most direct outlet of the gastrojejunostomy (3).
The treatment is revision bariatric surgery, most commonly laparoscopic resection of the afferent limb, which ranged in length from 3 to 22 cm in one study (mean of 7.6 cm) (3). Symptoms resolve after revision surgery in most patients. Surgeons should minimize the length of the blind afferent loop left at the time of initial RYGB to prevent candy cane Roux syndrome.
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.
- Conditions
- Bariatric Surgery, Complication
- Being tested
- Endomina
- Keywords
- endoscopy, mini invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndominaDevice
The jejunum between the two loops is sutered with Endomina and cut 15 days later.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Endomina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterisation of safety by measurement of the incidence of all adverse device effects (ADE)
Incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or the device.
Definitions are combined from EN ISO 14155:2011 and MEDDEV 2.7/3 rev 3 (May 2015).
Measured: 6 months
Secondary outcomes (1)
Efficacy of the device: Dakkak and Bennett dysphagia score
scoring using the Dakkak and Bennett dysphagia score 0 = no dysphagia; 4= aphagia Total scale will be reported
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start6 Mar 2018
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Deviere, MD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608267
- Sponsor's protocol ID
- SRB_201804_011 -- P2018/336
- Acronym
- Endomina
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2018
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jun 2020. 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 Afferent Loop Syndrome
- ClinicalTrials.gov ID
- NCT03608267
- Acronym / sponsor ID
- Endomina / SRB_201804_011 -- P2018/336
- Conditions
- Bariatric Surgery, Complication
- Keywords
- endoscopy, mini invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 31 Jul 2018 (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.
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 (1,2).
Morbidity after RYGB includes the candy cane syndrome or afferent loop syndrome. Candy cane Roux syndrome in patients who have undergone RYGB refers to an excessively long blind afferent Roux limb at the gastrojejunostomy causing postprandial pain often relieved by vomiting. It is believed that the blind afferent limb ("candy cane") acts as an obstructed loop when filled with food (often preferentially), and the distention of the loop causes pain until the food either spills into the Roux limb or is vomited back out (3).
Patients have been reported presenting as early as three months and as late as 11 years after their initial RYGB, typically with symptoms of postprandial epigastric pain, nausea, vomiting, and reflux or food regurgitation (4). The diagnosis is confirmed by upper gastrointestinal contrast studies or endoscopy. On upper gastrointestinal series, the afferent limb fills before contrast spills into the Roux limb. On upper endoscopy, the afferent limb is usually the most direct outlet of the gastrojejunostomy (3).
The treatment is revision bariatric surgery, most commonly laparoscopic resection of the afferent limb, which ranged in length from 3 to 22 cm in one study (mean of 7.6 cm) (3). Symptoms resolve after revision surgery in most patients. Surgeons should minimize the length of the blind afferent loop left at the time of initial RYGB to prevent candy cane Roux syndrome.
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.
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 (1,2).
Morbidity after RYGB includes the candy cane syndrome or afferent loop syndrome. Candy cane Roux syndrome in patients who have undergone RYGB refers to an excessively long blind afferent Roux limb at the gastrojejunostomy causing postprandial pain often relieved by vomiting. It is believed that the blind afferent limb ("candy cane") acts as an obstructed loop when filled with food (often preferentially), and the distention of the loop causes pain until the food either spills into the Roux limb or is vomited back out (3).
Patients have been reported presenting as early as three months and as late as 11 years after their initial RYGB, typically with symptoms of postprandial epigastric pain, nausea, vomiting, and reflux or food regurgitation (4). The diagnosis is confirmed by upper gastrointestinal contrast studies or endoscopy. On upper gastrointestinal series, the afferent limb fills before contrast spills into the Roux limb. On upper endoscopy, the afferent limb is usually the most direct outlet of the gastrojejunostomy (3).
The treatment is revision bariatric surgery, most commonly laparoscopic resection of the afferent limb, which ranged in length from 3 to 22 cm in one study (mean of 7.6 cm) (3). Symptoms resolve after revision surgery in most patients. Surgeons should minimize the length of the blind afferent loop left at the time of initial RYGB to prevent candy cane Roux syndrome.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Endomina |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Proven Candy cane syndrome by barium swallow
- Age between 18-65 years;
- 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;
Key exclusion criteria (9 listed)
- Achalasia and any other esophageal motility disorders;
- Severe esophagitis;
- Gastro-duodenal ulcer;
- 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 jejunum between the two loops is sutered with Endomina and cut 15 days later. | Device | Intervention |
Primary outcome
Characterisation of safety by measurement of the incidence of all adverse device effects (ADE)
Time frame: 6 months
Incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or the device. Definitions are combined from EN ISO 14155:2011 and MEDDEV 2.7/3 rev 3 (May 2015).
1 secondary outcome
Efficacy of the device: Dakkak and Bennett dysphagia score
Time frame: 6 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 30 Jun 2020.
- 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.
Jacques Deviere, MD principal investigator
Erasme University Hospital
2 sites 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 Bariatric Surgery and Complication, run by Erasme University Hospital at 2 sites 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 6 inclusion and 9 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 30 Jun 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. 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?
Characterisation of safety by measurement of the incidence of all adverse device effects (ADE) (time frame: 6 months). 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 30 Jun 2020.