Trial Outcomes & Findings for Use of Radiofrequency Ablation for RGB Salvage (NCT NCT01910688)

NCT ID: NCT01910688

Last Updated: 2016-06-24

Results Overview

EBWL 12 months after enrollment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2016-06-24

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	25
Overall Study 3.5month	25
Overall Study 2nd RFA Treatment	22
Overall Study 7.5months	24
Overall Study 3rd RFA Treatment	18
Overall Study 12months	22
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Radiofrequency Ablation for RGB Salvage

Baseline characteristics by cohort

Measure	RFA Treatment (Radiofrequency Ablation) n=25 Participants 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.
Age, Continuous	45.4 years STANDARD_DEVIATION 9.08 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

EBWL 12 months after enrollment

Outcome measures

Measure

RFA Treatment (Radiofrequency Ablation) n=22 Participants 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.

Excess Body Weight Loss After RFA Treatment

28.36 percentage of EBWL Standard Deviation 28.830

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	RFA Treatment (Radiofrequency Ablation) n=25 Participants 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.
Technical Feasibility: Percentage of Participants Who Completed RFA Treatment Day 0	84 percentage of participants
Technical Feasibility: Percentage of Participants Who Completed RFA Treatment Month 4	95.45 percentage of participants
Technical Feasibility: Percentage of Participants Who Completed RFA Treatment Month 8	94.44 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

RFA Treatment (Radiofrequency Ablation) n=25 Participants 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.

Patient Tolerability

12 number of events

SECONDARY outcome

Timeframe: 12 months

Adverse event profile: Relationship to study device : Definite, Probable, Possible

Outcome measures

Measure	RFA Treatment (Radiofrequency Ablation) n=25 Participants 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.
Adverse Events Definite	6 number of events
Adverse Events Possible	2 number of events
Adverse Events Probable	3 number of events

Adverse Events

RFA Treatment (Radiofrequency Ablation)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure

RFA Treatment (Radiofrequency Ablation) n=25 participants at risk 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.

Injury, poisoning and procedural complications GI bleed

8.0% 2/25 • Number of events 2

Other adverse events

Measure	RFA Treatment (Radiofrequency Ablation) n=25 participants at risk 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.
Injury, poisoning and procedural complications Dysphagia	8.0% 2/25 • Number of events 2
Injury, poisoning and procedural complications Mucosal Bleeding	8.0% 2/25 • Number of events 2
Injury, poisoning and procedural complications Fever	4.0% 1/25 • Number of events 1
Injury, poisoning and procedural complications Vomiting, Nausea	16.0% 4/25 • Number of events 5
Injury, poisoning and procedural complications Abdominal tenderness. Oesophageal pain	8.0% 2/25 • Number of events 3
Injury, poisoning and procedural complications Fatigue	4.0% 1/25 • Number of events 1

Additional Information

Dr. Julian Abrams

Columbia University Medical Center

Phone: (212) 235-1496

Email: ja660@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60