Assessing the safety and effectiveness of the BariClip device in the treatment of severe obesity in Jordan
| ISRCTN | ISRCTN98465849 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98465849 |
| Secondary identifying numbers | GBMC 00001 |
- Submission date
- 29/12/2022
- Registration date
- 16/02/2023
- Last edited
- 14/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Obesity and its associated disorders such as type 2 diabetes, nonalcoholic fatty liver disease, and cardiovascular (heart) disease have reached pandemic proportions worldwide. Conventional medical care offers only limited results, both in weight reduction and associated disorders. Bariatric surgery allows a significant and sustained weight loss in the majority of cases, a decrease in the frequency and severity of associated disorders, including type 2 diabetes, and decreased risk of death including from cardiovascular diseases. However, it requires a major abdominal surgery associated with an estimated 5% significant risk of illness after surgery and an average postoperative risk of death estimated at 0.3%. A new device has been developed which is basically a nonadjustable vertical clip. This device, the BariClip, placed parallel to the lesser curvature of the stomach, aims to restrict food intake without changing the stomach or small bowel anatomy, requires no stapling, causes no malabsorption, does not require any maintenance or surveillance, and is reversible. The aim of this study is to assess the safety and effectiveness of this device as a treatment for obesity and its related disorders.
Who can participate?
Adults between the age of 18 and 65 years with a BMI >40 kg/m² or a BMI >30 kg/m² with at least one associated disorder and a history of obesity for at least 5 years with failed dieting attempts
What does the study involve?
Participants will undergo a laparoscopic clip gastroplasty with the use of the BariClip device and will be followed up for a total of 60 months. Weight loss will be assessed at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months after implantation, and routine labs and imaging will be conducted on day 1, at 3 months, and at 24 months.
What are the possible benefits and risks of participating?
The clip offers a treatment for obesity and its associated disorders that causes fewer complications and is reversible.
Where is the study run from?
Jordan Hospital (Jordan)
When is the study starting and how long is it expected to run for?
December 2022 to June 2028
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Ashraf Haddad, Ashraf.haddad@gbmc-jo.com
Contact information
Principal Investigator
Gastrointestinal Bariatric and Metabolic Center (GBMC)
Jordan Hospital
Amman
11152
Jordan
| Phone | +962 (0)7 9557 2195 |
|---|---|
| Ashraf.haddad@gbmc-jo.com |
Scientific
Gastrointestinal Bariatric and Metabolic Center (GBMC)
Jordan Hospital
Amman
11152
Jordan
| Phone | +962 (0)7 9557 2195 |
|---|---|
| Ashraf.haddad@gbmc-jo.com |
Public
Gastrointestinal Bariatric and Metabolic Center (GBMC)
Jordan Hospital
Amman
11152
Jordan
| Phone | +962 (0)7 9557 2195 |
|---|---|
| Ashraf.haddad@gbmc-jo.com |
Study information
| Study design | Multicenter prospective single-arm clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Assessing weight loss, adverse events, and resolution of comorbid conditions associated with the use of the BariClip device in adult patients with severe obesity in Jordan |
| Study acronym | BariClip-Jo |
| Study objectives | The BariClip device provides a reversible alternative to sleeve gastrectomy that is just as efficacious in terms of weight loss. |
| Ethics approval(s) | 1. Approved 31/01/2023, the Institutional Review Boards of Jordan Hospital (Queen Nour Street, PO Box 520248, Amman, Jordan; +962 (0)795528298; jorhos@jordan-hospital.com, saeb.hammoudi@gmail.com), ref: not applicable 2. Approved 11/02/2023, Al Khalidi Hospital & Medical Center (39 Ibn Khaldoun Street, 4th Circle Jebal Amman, Jordan; +962 (0)795598687; Dr.Nael.kaf@khmc.jo), ref: KHMC/22/R/93 |
| Health condition(s) or problem(s) studied | Obesity and its associated disorders |
| Intervention | Laparoscopic vertical clip gastroplasty with the BariClip device. In the procedure, the clip is placed parallel to lesser curvature to separate the stomach into a restricted medial segment where food passes and an excluded larger lateral gastric segment. It aims to restrict oral intake without changing the gastric or small bowel anatomy, requires no stapling, causes no malabsorption, does not require any maintenance or surveillance, and is reversible. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | BariClip |
| Primary outcome measure | Percent Excess Weight Loss (%EWL) defined as weight loss divided by baseline excess weight. Excess weight will be determined from ideal body weight based on a BMI of 24.9 for normal adults (Center for Disease Control [CDC]) at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months post-implantation. |
| Secondary outcome measures | 1. Absolute weight loss over 60 months, defined simply as the total weight loss for the follow-up period 2. Total change in weight (TWL%) defined as (preoperative (preop) weight – follow up weight)/(preop weight) X 100%, measured at 12, 36 and 60 months 3. Total change in BMI (TBMIL%) defined as (preoperative (preop) BMI – follow up BMI)/(preop BMI) X 100%, measured at 12, 36 and 60 months 4. Plasma glucose levels, HbA1c levels, and resolution of T2DM (% of patients, defined as HbA1C<6) in diabetic patients measured annually over 5 years |
| Overall study start date | 01/12/2022 |
| Completion date | 30/06/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Age 18 – 65 years 2. Male or female 3. BMI >40 kg/m² and BMI >30 kg/m² with at least one comorbid condition (hypertension [HTN], type 2 diabetes [DT2], sleep apnea) 4. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure (written consent form) 5. History of obesity for at least 5 years 6. History of failure with dieting methods 7. Willingness to follow protocol requirements including signed consent, routine follow-up schedule, completing quality of life (QOL) questionnaires, completing laboratory tests, completing diet and behavior modification counseling 8. Residing within a reasonable distance from an investigating center and able to travel to the investigator to complete all routine follow-up visits |
| Key exclusion criteria | 1. Surgery or treatment represents an unreasonable risk to the subject 2. Patient history of inflammatory disease of the gastrointestinal (GI) tract (including ulceration, duodenal ulceration, grade 4 esophagitis, specific inflammation such as Crohn’s disease or ulcerative colitis) 3. Severe cardiopulmonary disease or other serious organic disease 4. Severe coagulopathy, upper gastrointestinal (UGI) bleeding conditions, such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia 5. Congenital or acquired anomalies of the GI 6. Severe hiatal hernia (>3 cm) 7. Pregnant or has the intention of becoming pregnant in the next 12 months 8. Alcohol or drug addiction, active smoker 9. Mental retardation or emotional instability, or psychological characteristics which, in the opinion of the investigators, make the subject a poor candidate for clip surgery 10. Previous esophageal, gastric surgery, hepatectomy, splenectomy 11. Previous endoscopic procedure for obesity 12. Patient under GLP1 medication or weight loss drug 13. Diabetes patient under treatment for gastroparesis 14. Previous bariatric surgery, intestinal obstruction, or adhesive peritonitis 15. Patient history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder 16. Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the Clip clinical trial |
| Date of first enrolment | 01/03/2023 |
| Date of final enrolment | 01/01/2025 |
Locations
Countries of recruitment
- Jordan
Study participating centres
Amman
11152
Jordan
Amman
11183
Jordan
Sponsor information
Hospital/treatment centre
Gastrointestinal, Bariatric & Metabolic Center
Jabal Amman, Queen Nour Street
Amman
11152
Jordan
| Phone | +962 (0)6 560 9067 |
|---|---|
| info@gbmc-jo.com | |
| Website | http://www.jordan-hospital.com/ |
"ROR" |
https://ror.org/036wxg427 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 13/02/2023 | No | No |
Additional files
Editorial Notes
13/02/2023: Trial's existence confirmed by the Institutional Review Boards of Jordan Hospital and Al Khalidi Hospital & Medical Center.
