Safety and Feasibility of Endomina, an Candy Cane Syndrome Endoluminal Suturing Device

NCT03608267 | Completed DMC

• 1 other identifier: SRB_201804_011 -- P2018/336
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief 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). 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

Keywords

endoscopy; mini invasive

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Secondary Outcomes (1)

• Efficacy of the device: Dakkak and Bennett dysphagia score

  6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Device: Endomina

Interventions

Endomina DEVICE

The jejunum between the two loops is sutered with Endomina and cut 15 days later.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• Anticoagulant therapy;
• Impending gastric surgery 60 days post intervention;
• Currently participating in other study

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (2)

CUB Hopital erasme

Anderlecht, 1070, Belgium

Location

Gastroenterology Department Erasme Hospital

Brussels, 1070, Belgium

Location

Study Officials

• Jacques Deviere, MD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 31, 2018
• Study Start: March 6, 2018
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)