Obesity
Conditions
Keywords
RGB Salvage, RFA
Brief summary
The present study will assess the feasibility of using endoscopic radiofrequency ablation (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased compliance after a failed Roux-en-Y gastric bypass.
Detailed description
Obesity is a leading cause of preventable death in the United States, with approximately 300,000 related deaths per year. The most commonly performed bariatric surgical interventions are Roux-en Y gastric bypass (RGB) and laparoscopic adjustable gastric band placement. Despite the overall initial success of RGB to induce significant EBWL in the majority of patients, significant weight regain occurs in about 25% of patients at 2+ years following surgery. Given the preliminary success of endoscopic, non-surgical salvage interventions for the failed (uncomplicated) RGB patient, the present study will assess the feasibility of using endoscopic radiofrequency ablation (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased compliance. A reduction of size and compliance may, as others have reported, result in re-establish weight loss and achieve an acceptable EBWL with minimal patient morbidity.
Interventions
DEVICERFA treatment
If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. History of RGB surgery at least 1 year prior to enrollment 2. Achievement of \> 40% EBWL after RGB 3. Weight regain of \> 25% of the lost weight at the time of enrollment. For example, if excess body weight was 50 kg prior to RGB, patient must have lost at least 20 kg after RGB, then regained at least 5 kg to be eligible for the present study 4. Age 18-70 inclusive 5. Subject is able to tolerate endoscopy and sedation 6. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form (ICF)
Exclusion criteria
1. History of any bariatric surgery other than RGB, including lap band 2. History or presence of a gastrogastric fistula or gastric pouch / jejunal ulceration 3. Gastrojejunostomy \> 4 cm in diameter (size estimated at time of endoscopy) 4. Perceived inability of the patient by the Investigator to comply with a post-treatment diet or medication regimen 5. History of alcohol, tobacco and/or controlled substance dependency that would impair the patient from complying with protocol requirements 6. Pregnancy 7. Subject is unable to provide informed consent for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excess Body Weight Loss After RFA Treatment | 12 months | EBWL 12 months after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Feasibility: Percentage of Participants Who Completed RFA Treatment | Day 0, month 4, month 8 | Technical feasibility of applying RFA to gastric pouch and gastrojejunostomy. This will be assessed by asking the physician for feedback on ease of use, ease of intubation and extubation,did the physician achieve tissue contact in targeted areas, was targeted area successfully ablated. |
| Patient Tolerability | 12 months | Patient tolerability of the procedure. Patient tolerability will be measured by assessing adverse events related to the device or procedure. The Investigator will assess each adverse event with respect to severity and relationship to the study device. |
| Adverse Events | 12 months | Adverse event profile: Relationship to study device : Definite, Probable, Possible |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RFA Treatment (Radiofrequency Ablation) If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.
RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | RFA Treatment (Radiofrequency Ablation) |
|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 9.08 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 25 |
| serious Total, serious adverse events | 2 / 25 |
Outcome results
Primary
Excess Body Weight Loss After RFA Treatment
EBWL 12 months after enrollment
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RFA Treatment (Radiofrequency Ablation) | Excess Body Weight Loss After RFA Treatment | 28.36 percentage of EBWL | Standard Deviation 28.83 |
Secondary
Adverse Events
Adverse event profile: Relationship to study device : Definite, Probable, Possible
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RFA Treatment (Radiofrequency Ablation) | Adverse Events | Definite | 6 number of events |
| RFA Treatment (Radiofrequency Ablation) | Adverse Events | Possible | 2 number of events |
| RFA Treatment (Radiofrequency Ablation) | Adverse Events | Probable | 3 number of events |
Secondary
Patient Tolerability
Patient tolerability of the procedure. Patient tolerability will be measured by assessing adverse events related to the device or procedure. The Investigator will assess each adverse event with respect to severity and relationship to the study device.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RFA Treatment (Radiofrequency Ablation) | Patient Tolerability | 12 number of events |
Secondary
Technical Feasibility: Percentage of Participants Who Completed RFA Treatment
Technical feasibility of applying RFA to gastric pouch and gastrojejunostomy. This will be assessed by asking the physician for feedback on ease of use, ease of intubation and extubation,did the physician achieve tissue contact in targeted areas, was targeted area successfully ablated.
Time frame: Day 0, month 4, month 8
Population: At 0 month, 25 received 1st RFA treatment; at 4 month, 22 received 2nd RFA treatment; at 8 month, 18 received RFA Treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RFA Treatment (Radiofrequency Ablation) | Technical Feasibility: Percentage of Participants Who Completed RFA Treatment | Day 0 | 84 percentage of participants |
| RFA Treatment (Radiofrequency Ablation) | Technical Feasibility: Percentage of Participants Who Completed RFA Treatment | Month 4 | 95.45 percentage of participants |
| RFA Treatment (Radiofrequency Ablation) | Technical Feasibility: Percentage of Participants Who Completed RFA Treatment | Month 8 | 94.44 percentage of participants |