NCT07004439

Brief Summary

A post-market retrospective and prospective, open label, multicenter, single-arm registry study using standard clinical procedures to record available and/or new data to evaluate the safety and performance of RefluxStop™ for the treatment of subjects suffering from GERD. Following surgery, patients will have follow-ups visits at 3 and 6 months and annually up to 7 years.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
112mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Sep 2025Aug 2035

First Submitted

Initial submission to the registry

May 27, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2035

Last Updated

June 4, 2025

Status Verified

March 1, 2025

Enrollment Period

3.9 years

First QC Date

May 27, 2025

Last Update Submit

May 27, 2025

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • Reduction of Patient Reported Outcome - Side effects (PROS)

    Patient Reported Outcome - Side effects (PROS) combine the established side effects: Dysphagia, Odynophagia, Inability to Belch, Inability to Vomit, and worsened Gas bloating, compared to baseline

    1 year

Secondary Outcomes (2)

  • Incidence of safety events

    3 and 6 months and years 1 to 7

  • Reduction of Patient Reported Outcome - Side effects (PROS)

    6 months and years 2 to 7

Study Arms (1)

Single arm: intervention

OTHER

Single arm registry: all enrolled patients will be implanted with RefluxStopTM

Device: RefluxStop™ implantation

Interventions

RefluxStop™ implantationDEVICE

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

Single arm: intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to provide informed consent and to participate in the registry study;
  • Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
  • Documented GERD present for ≥ 6 months. Typical symptoms are defined as heartburn;
  • hour pH or impedance pH monitoring proven GERD with pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be \< 4 for ≥ 4.5% of total time during a 24-hour monitoring) and/or total reflux episodes \>55 or weekly acid \>26 for \> 5 seconds, all measured 5 cm above LES);
  • Suitable to undergo general anaesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.

You may not qualify if:

  • Hiatal Hernia larger than 8 cm;
  • Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed. Patients with substantially weak peristalsis (manometry DCI value 100-200) in esophagus measured during manometry would continue the simplified contrast swallow x-ray to perform a simplified two-hour gastric emptying contrast swallow
  • History of bariatric surgery wherein the stomach fundus has been extirpated;
  • Female subjects who are pregnant;
  • Known sensitivity or allergies to silicone materials;
  • Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry procedure (as outlined in the IFU);
  • Subjects that are unable to comply with the registry requirements (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the clinical investigation according to the investigator's judgement).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Klinikum Friedrichshafen GmbH

Friedrichshafen, Germany

Location

H. Universitario Getafe

Getafe, Madrid, Spain

Location

H. La Mancha Centro

Alcázar de San Juan, Spain

Location

H. Infanta Sofía

Madrid, Spain

Location

H. Ramón y Cajal

Madrid, Spain

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

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

May 27, 2025

First Posted

June 4, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2035

Last Updated

June 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)ES(4)