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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-20

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroesophageal Reflux Disease (GERD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RefluxStop patients

RefluxStop implantation

Intervention Type DEVICE

Standard surgical technique for implantation RefluxStop, as described in the Itructions for Use

Nissen fundoplication patients

Nissen fundoplication

Intervention Type PROCEDURE

Standard of care Nissen fundoplication surgery

Interventions

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RefluxStop implantation

Standard surgical technique for implantation RefluxStop, as described in the Itructions for Use

Intervention Type DEVICE

Nissen fundoplication

Standard of care Nissen fundoplication surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Willing and able to provide informed consent and to participate in the registry study,
2. Patient's age ≥ 18 years or according to local legal age of adulthood if older,
3. Documented GERD present for \> 6 months,
4. 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)
5. Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.

Exclusion Criteria

1. Presence of para-esophageal hernia or sliding hernia \> 3 centimeters,
2. Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed,
3. History of bariatric surgery wherein the stomach fundus has been extirpated,
4. Female patients who are pregnant or nursing,
5. Known sensitivity or allergies to silicone materials,
6. Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry study procedure (as outlined in the IFU);
7. Patients that are unable to comply with the registry study requirements, (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the registry study according to the investigator's judgement).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No