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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01327963
Other study ID # D01079
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2010
Est. completion date February 2014

Study information

Verified date November 2020
Source EndoGastric Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States.


Description:

This retrospective, open-label, post-market study evaluates the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States, in clinical routine practice, as standard of care.


Recruitment information / eligibility

Status Terminated
Enrollment 110
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Age 18-85 years - Have undergone the TIF procedure within the past 2 years - History of daily proton pump inhibitor (PPI) use for >6 months - Proven gastroesophageal reflux by either endoscopy, ambulatory potential of hydrogen (pH) or moderate to severe symptoms on or off PPIs - Deteriorated gastroesophageal junction (Hill grade II or III) - Availability for a follow-up visit at 6,12 or 24 months - Willingly and cognitively signed informed consent Exclusion Criteria: - Procedure not completed or performed following a non-standardized TIF protocol - Subjects suffering from other gastrointestinal (GI) conditions such as dyspepsia, celiac disease, Irritable bowel syndrome (IBS) or Crohn's disease - Pregnancy - Enrollment in another device or drug study that may confound the results

Study Design


Intervention

Device:
Transoral Incisionless Fundoplication
Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless Fundoplication 2.0 technique iteration (TIF2.0) protocol.

Locations

Country Name City State
United States Munroe Regional Medical Center Ocala Florida
United States Livingston Hospital and Healthcare Services, Inc. CAH Salem Kentucky

Sponsors (1)

Lead Sponsor Collaborator
EndoGastric Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination Typical and atypical GERD symptom elimination in GERD Health-Related Quality of Life (GERD-HRQL). HRQL questionnaire measures typical GERD symptoms, scale 0-5 for each of 9 questions; scores considered normalized if every score is 0), GERD Symptom Score (GERSS measures atypical GERD symptoms, scale 0-3 for severity and 0-4 for frequency, with total scale 0-60; patients with controlled reflux symptoms are expected to have a score of <18) and Reflux Symptom Index (RSI measures atypical laryngopharyngeal (LPR) symptoms, scale 0-5 for each of 9 questions with maximum of 45 with a normality threshold of < or = 13) questionnaires) at the follow-up. median 7 months (range 5-17 months)
Secondary Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs) The treatment will be considered safe if the incidence of serious adverse events (SAEs) is below the ranges reported for laparoscopic fundoplication. median 7 months (range 5-17 months)
Secondary Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use Patients reporting complete discontinuation of daily PPI use will be considered clinically significant. median 7 months (range 5-17 months)
Secondary Number of Participants With Healing of Reflux Esophagitis One LA grade reduction will be considered clinically significant. LA grades are A, B, C, D, with A being the least severe esophagitis. No grade assigned is considered "normal", i.e. no esophagitis reported. median 7 months (range 5-17 months)
Secondary Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up Measurement obtained by study investigator, under endoscopic visualization using cm markings on the endoscope. Outcome measure assesses if hiatal hernia that was present at baseline and reduced (size reduction to < 1 cm is considered clinically significant) during TIF procedure, has remained reduced at the post-TIF follow up exam. median 7 months (range 5-17 months)
Secondary Number of Participants With Normalization or Clinically Significant Improvement in Esophageal Acid Exposure Assessed by Impedance/pH Testing and Reflux Episodes Esophageal acid exposure will be measured objectively by 48-hour Bravo Potential of Hydrogen (pH) or 24-hour impedance/pH testing at the follow-up (where pH testing is available). Normalization of esophageal acid exposure will be defined by total time pH< 4 for = 6% of 24-hour or for = 5.3% of 48-hour monitoring period. The number of reflux episodes of = 44 per each 24-hour period will be considered normal. median 7 months (range 5-17 months)
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