Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment

ConditionGastroesophageal Reflux Disease (GERD)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorImplantica CE Reflux Ltd.

About this trial

This post-market registry aims to assess safety and performance of RefluxStop™ in the treatment of Gastroesophageal Reflux Disease (GERD) in standard of care procedures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to provide informed consent and to participate in the registry study,

Patient's age ≥ 18 years or according to local legal age of adulthood if older,

Documented GERD present for > 6 months,

Patient has a 24-hour pH monitoring proven GERD with pH and/or impedance pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be <4 for >4.5% of time during a 24-hour monitoring and/or total reflux episodes of acid >55 or weakly acid >26 for >5 seconds at 5 cm above LES)

Disqualifiers

Presence of para-esophageal hernia or sliding hernia > 3 centimeters,

Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed,

History of bariatric surgery wherein the stomach fundus has been extirpated,

Female patients who are pregnant or nursing,

Trial population

RefluxStop device and Nissen fundoplication are indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) defined by abnormal pH testing.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

RefluxStop implantation
Device
Standard surgical technique for implantation RefluxStop, as described in the Itructions for Use
Nissen fundoplication
Procedure/Surgery
Standard of care Nissen fundoplication surgery

Treatment groups

2,500 Participants

are divided into 2 treatment groups

Group A: RefluxStop patients1 intervention

Group B: Nissen fundoplication patients1 intervention

Trial outcomes

Primary outcomes

Primary safety endpoint

Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs)

Time frame

6 months

Primary performance endpoint

Assessment of GERD symptoms, measured by GERD Health-Related Quality of Life (HRQL) score (questions 1-10). (An answer of zero means no symptoms)

Time frame

6 months

Secondary outcomes

Secondary safety endpoint

Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs) at 3 months and annually up to 5 years. Plus Incidence of Adverse Device Effects (ADEs) and procedure related or unknown Adverse Events (AEs) at 3 and 6 months and annually up to 5 years

Time frame

3 and 6 months and annually up to 5 years

Secondary performance endpoints

Assessment of GERD symptoms, assessed by GERD-HRQL score (questions 1-10)

Time frame

3 months and annually up to 5 years

Secondary performance endpoints: RefluxStop device position

Location and function of the device evaluated by a simplified contrast swallow x-ray with overview pictures of device

Time frame

6 months

Secondary performance endpoints: hernia assessment

Location of baseline hernia or any new hernia by a simplified contrast swallow x-ray picture

Time frame

6 months

Other outcomes

Exploratory endpoints: Patient Reported Outcomes - Quality of life questionnaire

EQ-5D (Euro Quality of life-5 Dimension) questionnaire: measure of quality of life with one question for each of the five dimensions that are mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, the patients assess if they have no problem, slight, moderate, severe or extreme problems.

Time frame

3 and 6 months and annually up to 5 years

Exploratory endpoints: Patient Reported Outcomes - Work related questionnaire

WPAI (work related productivity gains): 5 questions to assess how health problems effect the patient work Score 0 to 10. Zero meaning health problems have no effect on work

Time frame

3 and 6 months and annually up to 5 years

Exploratory endpoints: Health economic outcomes - Visit to General Practitioner

Evaluation of number of visit to the General Practitioner

Time frame

3 and 6 months and annually up to 5 years

Exploratory endpoints: Health economic outcomes - PPI treatment use

Counting of the number of patients using PPI (Proton Pump Inhibitors)

Time frame

3 and 6 months and annually up to 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Implantica CE Reflux Ltd.

Lead sponsor

Source ClinicalTrials.gov

Apply now