Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of GERD

NCT02759094 | Unknown DMC

• 1 other identifier: RXI 001
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 4

Brief Summary

Prospective, open-label, multi-centre, single arm treatment only trial to evaluate the safety and effectiveness of RefluxStop for the treatment of GERD. The used medical device "RefluxStop" is an implantable single use sterile device to ensure maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or eliminate GERD.

Conditions

GERD

Keywords

GERD; Implantable medical device; RefluxStop; Reflux; Gastroesophageal Reflux; Laparoscopy; pH-Monitoring; PPI proton pump inhibitors

Outcome Measures

Primary Outcomes (2)

• Primary safety endpoint

  Assessment of incidence of serious adverse device effects (SADEs) and procedure-related serious adverse events (SAEs)

  at 6 months

• Primary efficacy endpoint

  Percent reduction from baseline of GERD symptoms based on the GERD-HRQL score (questions 1-10). The data will also be presented as the number of subjects obtaining a 50% improvement of the baseline figures, with success defined as 60% of the subjects to reach such score improvement. Thus, the aim of this analysis is to show that the lower limit of the confidence interval exceeds 60%.

  at 6 months

Secondary Outcomes (8)

• Secondary safety endpoint

  at 6 weeks, 3 months, 6 months (ADEs and AEs only) and annually years 1-5

• Secondary efficacy endpoint: HRQL all other timepoints

  measured at baseline, 6 weeks, 3 months and follow-up years 1-5

• Secondary efficacy endpoint: additional questions

  measured at baseline, 6 weeks, 3 months, 6 months and follow up years 1-5

• Secondary efficacy endpoint: 24-hr pH monitoring

  measured at baseline, 6 months, 5 years and if therapy failure

• Secondary efficacy endpoint: PPI usage

  measured at baseline, 6 weeks, 3 months, 6 months and follow up years 1-5

Other Outcomes (4)

• Secondary efficacy subgroup endpoint

  per patient any point in the study triggered either by regular daily PPI usage or a GERD-HRQL score with less than 50% improvement compared to baseline, and having been verified as therapy failure via 24-hr pH monitoring and x-ray results

• Exploratory endpoint: procedure complications

  during procedure

• Exploratory endpoint: Procedure time

  during procedure

Study Arms (1)

Treatment with RefluxStop device

EXPERIMENTAL

All enrolled subjects will receive treatment for their GERD using the RefluxStop device intervention

Device: Treatment with RefluxStop

Interventions

Treatment with RefluxStop DEVICE

A standard laparoscopic approach will be used to reposition the lower oesophageal sphincter (LES) to its intra-abdominal position. The RefluxStop device will be then positioned and fixed in the gastric funds to ensure intra-abdominal positioning of the GEJ (Gastro-oesophageal Junction) at all time. After confirming proper placement, the laparoscopic implant procedure will be completed and access points will be closed.

Treatment with RefluxStop device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject's age \>= 18 years and \<= 75 years
• Subject is able to undergo general anaesthesia and is a suitable laparoscopic surgical candidate
• Subject is willing and able to participate
• Subject has provided written informed consent after being informed of the study procedure and risks prior to any study-related events
• Subject has documented typical GERD symptoms present for \> 6 months which respond to PPIs as anti-GERD medication. Typical symptom of GERD is defined as heartburn, which is a burning epigastric or substernal pain
• Subject requires daily PPI anti GERD medication
• Subject has a 24-hour pH monitoring proven GERD performed taken off any anti reflux medication or after discontinuation for at least 7 days prior to testing. Total distal esophageal pH must be \<= 4 for \>= 4.5% if time during a 24-hour monitoring

You may not qualify if:

• Subject is currently participating in another study involving investigational drugs or devices
• Subject has a history of gastro esophageal surgery, anti-reflux or bariatric procedure
• Subject has a history of endoscopic anti-reflux intervention
• Subject has a history or a suspicion of esophageal or gastric cancer
• Subject has a history of major psychiatric disorder
• Presence of a para-esophageal hernia or sliding hernia of \> 3cm determined on endoscopy
• Presence of an esophagitis grade C or D according to the Los Angeles classification
• Presence of esophageal dysmotility disorder such as but not limited to scleroderma, achalasia, Nutcracker oesophagus
• Presence of esophageal stricture or stenosis
• Presence of delayed gastric emptying
• Presence of esophageal or gastric varies
• Subject has a body mass index (BMI) \> 35kg/m2
• Female subjects who are pregnant or nursing
• Known sensitivity or allergies to silicone materials
• Subjects who are unable to comply with the protocol requirements

Sponsors & Collaborators

• Implantica CE Reflux Ltd.: lead

Study Sites (4)

Semmelweis University

Budapest, 1082, Hungary

Location

University of Debrecen, Kenezy Gyula Teaching Hospital, General Surgery Department

Debrecen, 4031, Hungary

Location

Fejer County Szent Gyorgy University Teaching Hospital, Surgical Department

Székesfehérvár, H-8000, Hungary

Location

Clinical Center of Serbia, Clinic for Digestive Surgery

Belgrade, 11000, Serbia

Location

Related Publications (1)

• Bjelovic M, Harsanyi L, Altorjay A, Kincses Z, Forsell P; Investigators of the RefluxStop Clinical Investigation Study Group. Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results : RefluxStop device; a new method in acid reflux surgery obtaining CE mark. BMC Surg. 2020 Jul 20;20(1):159. doi: 10.1186/s12893-020-00794-9.

  PMID: 32689979 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• László Harsányi, Prof.

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: May 3, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2023
• Last Updated: April 6, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); HU (3)