Gastro-oesophageal Reflux Disease Trial, Recruiting NCT05870163 Sponsor: Implantica CE Reflux Ltd. Condition: Gastro-oesophageal Reflux Disease
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Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT05870163
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing and able to give informed consent and take part in the study.
  • People who are 18 years of age or older (or the legal age of adulthood in their country, if that is older than 18).
  • People who have had documented gastroesophageal reflux disease (acid reflux) for more than 6 months.
  • People whose acid reflux has been confirmed by a 24-hour pH monitoring test (a test that measures acid levels in the food pipe), taken after stopping acid-reducing medication for at least 7 days, with results meeting specific thresholds for acid exposure or reflux episodes (confirm with trial site for exact values).
  • People who a doctor has assessed as suitable to have a procedure under general anaesthetic using keyhole (laparoscopic) surgery.

Who may not be able to join:

  • People who have a hiatal hernia (where part of the stomach pushes up into the chest) larger than 3 centimetres.
  • People known to have slow stomach emptying, where no other cause for their acid reflux has been identified.
  • People who have previously had weight-loss (bariatric) surgery in which part of the stomach (the fundus) was removed.
  • People who are pregnant or breastfeeding.
  • People with a known sensitivity or allergy to silicone materials.
  • People in whom the surgeon finds something during the procedure that makes it unsuitable to continue with the study, as outlined in the device instructions.
  • People who are unable to follow the study requirements, for example due to a significant mental health condition, or who the investigator considers otherwise unsuitable for participation.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Yves Borbély, Dr. med., Inselspital, Universitätsspital Bern

Phone: +41 78 249 77 28

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Implantica CE Reflux Ltd.
Registry
ClinicalTrials.gov
Start date
20 February 2023
Est. completion
1 December 2025

Where this trial is recruiting

🇩🇪 Germany 🇮🇹 Italy 🇳🇴 Norway 🇨🇭 Switzerland

Primary endpoints

Primary safety endpoint; Primary performance endpoint

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov