The EndoGastric Solutions TEMPO Trial

NCT01647958 | Completed Results

• 1 other identifier: D01292
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with refractory symptoms on Proton Pump Inhibitors (PPIs).

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

TEMPO; TIF; Transoral Incisionless Fundoplication; EsophyX System; refractory symptoms; proton pump inhibitors; EndoGastric Solutions; EGS; Acid Reflux; Heartburn; Regurgitation

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting GERD (Gastroesophageal Reflux Disease) Symptom Elimination or Clinically Significant Improvement Evaluated by RSI (Reflux Symptom Index) and RDQ (Reflux Disease Questionnaire).

  Elimination or clinically significant improvement in GERD symptoms, other than heartburn, refractory to PPI, evaluated by Reflux Symptom Index (RSI):9-item questionnaire measures atypical symptoms: hoarseness, throat clearing, excess throat mucus, dysphagia, cough. Scale for each item ranges from 0 (no problem) to 5 (severe), with max total score of 45, normality threshold of ≤13. Reflux Disease Questionnaire (RDQ):12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Scores calculated as mean of item responses with higher scores indicating more severe or frequent symptoms.

  6 months

• Number of Participants Reporting Elimination of Daily Troublesome Regurgitation Using a Validated Questionnaire for Assessment

  Elimination or clinically significant improvement in troublesome regurgitation refractory to PPIs as evaluated by the disease-specific and validated instrument, Reflux Disease Questionnaire (RDQ):12-item questionnaire assesses frequency and severity of heartburn (4 items measure frequency and severity of pain and burning behind breastbone), regurgitation (4 items measuring the frequency and severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses range from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Patient's score is calculated as the mean of item responses with higher scores indicating more severe or frequent symptoms. A frequency score of 3 or more and severity score of 2 or more for the regurgitation questions were required to meet the Montreal consensus criteria for troublesome regurgitation.

  6 months

Secondary Outcomes (3)

• Number of Participants With Complete PPI Discontinuation Assessed Using Validated Questionnaires and Participant-reported Discontinuation

  6 Months

• Number of Participants With Normalization of Esophageal Acid Exposure Assessed Using 48-hour pH Metry

  6 Months

• Number of Participants With Complete Healing or Reduction of Reflux Esophagitis, Assessed by EGD Using Los Angeles (LA) Grading

  6 months

Other Outcomes (1)

• Number of Participants With Elimination of Daily Troublesome Heartburn Assessed Using a Validated Questionnaire

  6 months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.

Device: EsophyX System with SerosaFuse fasteners

Control

ACTIVE COMPARATOR

Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial. Patients will be offered TIF crossover procedure upon completion of month-6 follow-up visit.

Drug: PPI

Interventions

EsophyX System with SerosaFuse fasteners DEVICE

Transoral Incisionless Fundoplication (TIF)/Transoral incisionless esophago-gastric fundoplication using the EsophyX System with SerosaFuse fasteners

Treatment Arm

PPI DRUG

Control Arm participants will take maximum standard dose of PPI during Initial Study period

Also known as: same brand of PPI used by all Control Arm participants

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years;
• GERD for \> 1 year;
• History of daily PPIs for \> 6 months;
• At least daily bothersome medically refractory GERD symptom(s) other than heartburn on PPIs;
• Hill grade I and II at gastroesophageal junction;
• Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing;
• Willingness to undergo pH testing;
• Willingness to cooperate with the postoperative diet;
• Availability for follow-up visits at 6, 12, 24, and 36 months;
• Willingly and cognitively signed inform consent

You may not qualify if:

• BMI \> 35 Hiatal hernia \> 2c m in axial height and \> 2 cm in greatest transverse dimension;
• Esophagitis grade C and D;
• Barrett's esophagus \> 2 cm;
• Esophageal ulcer;
• Fixed esophageal stricture or narrowing;
• Portal hypertension and/or varices;
• Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis;
• Gastroparesis;
• Coagulation disorders;
• History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis;
• Pregnancy or plans of pregnancy in the next 12 months;
• Enrollment in another device or drug study that may confound the results

Sponsors & Collaborators

• EndoGastric Solutions: lead

Study Sites (1)

EndoGastric Solutions

Redmond, Washington, 98052, United States

Location

Related Publications (1)

• Trad KS, Simoni G, Barnes WE, Shughoury AB, Raza M, Heise JA, Turgeon DG, Fox MA, Mavrelis PG. Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study. BMC Gastroenterol. 2014 Oct 6;14:174. doi: 10.1186/1471-230X-14-174.

  PMID: 25284142 DERIVED

Related Links

• EndoGastric Solutions Company Page

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Adrian Lobontiu
• Organization: EndoGastric Solutions

alobontiu@endogastricsolutions.com

650-474-9259

Study Officials

• Karim Trad, MD, FACS

  Reston Surgical Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: July 24, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2017
• Last Updated: November 23, 2020
• Results First Posted: November 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)