Trial Outcomes & Findings for Management of Reflux After Sleeve Using Stretta (NCT NCT02637713)

Results Overview

RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

6 months

Results posted on

2024-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Radiofrequency Energy to the Lower Esophageal Sphincter (LES) All patients that have undergone sleeve gastrectomy as treatment for obesity that have developed severe reflux symptoms will be treated with Stretta (FDA approved device for the management of GERD) and evaluated prospectively for resolution/improvement of reflux symptoms. Stretta: Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED. Radiofrequency (RF) Energy to the LES (Stretta Procedure): The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures.
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiofrequency Energy to the Lower Esophageal Sphincter (LES) All patients that have undergone sleeve gastrectomy as treatment for obesity that have developed severe reflux symptoms will be treated with Stretta (FDA approved device for the management of GERD) and evaluated prospectively for resolution/improvement of reflux symptoms. Stretta: Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED. Radiofrequency (RF) Energy to the LES (Stretta Procedure): The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures.
Overall Study Screen Failure	2

Baseline Characteristics

Management of Reflux After Sleeve Using Stretta

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiofrequency Energy to the Lower Esophageal Sphincter (LES) n=5 Participants All patients that have undergone sleeve gastrectomy as treatment for obesity that have developed severe reflux symptoms will be treated with Stretta (FDA approved device for the management of GERD) and evaluated prospectively for resolution/improvement of reflux symptoms. Stretta: Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED. Radiofrequency (RF) Energy to the LES (Stretta Procedure): The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African-American	1 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic	2 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Study was terminated early and no 6 month RSI data were collected. As such, there were no RSI scores to aggregate and report.

RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Population: Study was terminated early and no 12 month RSI data were collected. As such, there were no RSI scores to aggregate and report.

RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 months

Population: Study was terminated early and no 24 month RSI data were collected. As such, there were no RSI scores to aggregate and report.

RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Study was terminated early and no 6 month GERD-HRQL data were collected. As such, there were no results to aggregate and report.

GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Population: Study was terminated early and no 12 month GERD-HRQL data were collected. As such, there were no results to aggregate and report.

GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 months

Population: Study was terminated early and no 24 month GERD-HRQL data were collected. As such, there were no results to aggregate and report.

GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Esophageal samples were not collected and therefore there was no esophageal pH results to report.

All patients will have pH monitoring conducted at baseline pre-procedurally. The number of patients with abnormal pH levels will be tabulated. Bravo capsule monitoring will be used for evaluation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated early. Esophageal samples were not collected and therefore there was no esophageal pH results to report.

If esophageal pH levels at baseline are determined to have been abnormal, the number of patients with symptomatic GERD demonstrating an improvement in esophageal pH exposure following sleeve gastrectomy will be assessed. Bravo capsule monitoring will be used for evaluation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Study was terminated early. Esophageal samples were not collected and therefore there was no esophageal pH results to report.

If esophageal pH levels at baseline are determined to have been abnormal, the number of patients with symptomatic GERD demonstrating an improvement in esophageal pH exposure following sleeve gastrectomy will be assessed. Bravo capsule monitoring will be used for evaluation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Study was terminated early and data related to the use of anti-reflux medications was not collected. As such, there were no related anti-reflux medication data to aggregate and report.

The number of patients using anti-reflux medications will be tabulated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated early and data related to the cessation or decreased use of anti-reflux medications was not collected. As such, there were no related anti-reflux medication data to aggregate and report.

The number of patients who demonstrate a complete cessation or decrease in use of anti-reflux medications will be tabulated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (up to 4 hours)

Population: Study was terminated early and the gastric emptying study was not collected. As such, there were no related gastric emptying data to aggregate and report.

A Gastric emptying study will be conducted for all patients at 1, 2, 3, and 4 hours. Patients with severe gastroparesis (\>50% retention at 4 hours) will be excluded from study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated early and data related to gastric dysmotility as a contributing factor to GERD was not collected. As such, there were no 6 month gastric dysmotility results to aggregate and report.

If gastric dysmotility is determined to have been abnormal at baseline, the gastric emptying study will be repeated at 6 months to evaluate Gastric Dysmotility will be evaluated as a contributory factor in GERD following sleeve gastrectomy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Study was terminated early and data related to gastric dysmotility as a contributing factor to GERD was not collected. As such, there were no 12 month gastric dysmotility results to aggregate and report.

If gastric dysmotility is determined to have been abnormal at baseline, the gastric emptying study will be repeated at 12 months to evaluate Gastric Dysmotility will be evaluated as a contributory factor in GERD following sleeve gastrectomy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Biopsies were not obtained at baseline and, as such, there were no corresponding results to analyze and report.

An EGD will be obtained for all patients at baseline. Biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathophysiology.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study was terminated early. Biopsies were not obtained at 6 months and, as such, there were no corresponding results to analyze and report.

In those patients identified to have abnormal esophageal pathology at baseline, biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathology. The number of patients demonstrating objective histologic improvement or resolution of esophagitis will be determined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Study was terminated early. Biopsies were not obtained at 12 months and, as such, there were no corresponding results to analyze and report.

In those patients identified to have abnormal esophageal pathology at baseline, biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathology. The number of patients demonstrating objective histologic improvement or resolution of esophagitis will be determined.

Outcome measures

Outcome data not reported

Adverse Events

Radiofrequency Energy to the Lower Esophageal Sphincter (LES)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erin Moran-Atkin

Montefiore Medical Center

Phone: 718-920-4800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place