GERDNCT02762487
RELIEF Europe Study
A study testing The LINX® Reflux Management System in people with GERD and Gastroesophageal Reflux Disease, run by Torax Medical Incorporated at 4 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the LINX device in patients who have previously undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal reflux disease (GERD). The study will monitor safety and changes in reflux symptoms. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- GERD, Gastroesophageal Reflux Disease, Obesity
- What is being tested?
- The LINX® Reflux Management System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic sleeve gastrectomy (LSG) for obesity >12 months prior to proposed device implantation date.
- Patient is a surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery.
- Documented pathologic esophageal acid exposure by pH monitoring per institution's standard of care (i.e. total distal ambulatory esophageal pH< 4 for ≥ 5.3% (BRAVO) or ≥4.5% (transnasal) or abnormal DeMeester Score (>14.72) within 12 months of proposed implantation date (After Sleeve Gastrectomy).
- NOTE: SUBJECTS SHALL HAVE DISCONTINUED ALL GERD MEDICATIONS FOR AT LEAST 7 DAYS PRIOR TO TESTING WITH THE EXCEPTION OF ANTACIDS, WHICH MAY BE TAKEN UP UNTIL THE MORNING OF THE VISIT.
- Chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
- Age ≥ 21 years
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- At least 30% loss of excess weight from date of original LSG surgery.
- Patient is willing and able to cooperate with follow-up examinations.
- Patient has been informed of the study procedures and the treatment and has signed an informed consent form.
Who cannot join
- Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
- Prior surgery in the area of the gastroesophageal junction (GEJ), including prior hiatal hernia repair.
- Presence of ˃3 cm hiatal hernia as determined by endoscopy or barium esophagram.
- Subject had any major complications related to the laparoscopic sleeve gastrectomy that may interfere with, or increase the risks of the LINX procedure (such as, but not limited to, leaks from the gastric remnant and infection at the sleeve gastrectomy).
- Plans to surgically revise the gastric pouch (either known preoperatively or decided intraoperatively).
- Currently being treated with another investigational drug or investigational device.
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- Suspected or confirmed esophageal or gastric cancer or prior gastric or esophageal surgery or endoscopic intervention for GERD (with the exception of sleeve gastrectomy).
- Distal amplitude <35 mmHg or <70% peristaltic sequences.
- Presence of esophagitis - Grade C or D (LA Classification). BMI >35.
- Symptoms of dysphagia more than once per week within the last 3 months.
- Diagnosed with Scleroderma.
- Diagnosed with an esophageal motility disorder such as but not limited to achalasia, nutcracker esophagus, or diffuse esophageal spasm or hypertensive LES.
- Patient has a history of or known esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.).
- Patient has esophageal or gastric varices.
- Patient has Barrett's esophagus.
- Patient cannot understand trial requirements or is unable to comply with follow-up schedule.
- Pregnant or nursing, or plans to become pregnant during the course of the study.
- Any reason which the Investigator believes may cause the subject to be non-compliant with or unable to meet the protocol requirements.
- Patient has an electrical implant or metallic, abdominal implants.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Schön Klinik Nürnberg
Fürth, 90763
EvK Herne
Herne, 44623
Uni Klinik Leipzig
Leipzig
About this study
Official title: RELIEF Europe Study. A Prospective, Multicenter Study of RefluxManagement With the LINX® System for Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
The purpose of this study is to evaluate the LINX device in patients who have previously undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal reflux disease (GERD). The study will monitor safety and changes in reflux symptoms.
- Being tested
- The LINX® Reflux Management System
- Medical subject headings
- Gastroesophageal Reflux, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The LINX® Reflux Management SystemDevice
Also called LINX device
The LINX device is a permanent implant placed at the area of the lower esophageal sphincter (LES) and is designed to augment a weak LES and minimize or eliminate GERD-related symptoms.
| Study group | Role | What they receive |
|---|---|---|
| LINX arm | Experimental | Previous LSG patient will be treated with the LINX device and serve as their own control Receives: Device: The LINX® Reflux Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is GERD-HRQL Score as a measure of efficacy
Measured: Baseline, 6 month visit
Number of participants with serious complications as a measure of safety.
Measured: 6 month visit
Change is total distal acid exposure as a measure of efficacy.
Measured: Baseline, 6 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startNov 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torax Medical Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762487
- Sponsor's protocol ID
- 4700
- Status last verified
- Oct 2017
- First submitted
- 3 May 2016
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIEF Europe Study. A Prospective, Multicenter Study of RefluxManagement With the LINX® System for Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02762487
- Acronym / sponsor ID
- 4700
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Torax Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the LINX device in patients who have previously undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal reflux disease (GERD). The study will monitor safety and changes in reflux symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LINX arm | Experimental | Device: The LINX® Reflux Management SystemPrevious LSG patient will be treated with the LINX device and serve as their own control |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Laparoscopic sleeve gastrectomy (LSG) for obesity >12 months prior to proposed device implantation date.
- Patient is a surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery.
- Documented pathologic esophageal acid exposure by pH monitoring per institution's standard of care (i.e. total distal ambulatory esophageal pH< 4 for ≥ 5.3% (BRAVO) or ≥4.5% (transnasal) or abnormal DeMeester Score (>14.72) within 12 months of proposed implantation date (After Sleeve Gastrectomy).
- NOTE: SUBJECTS SHALL HAVE DISCONTINUED ALL GERD MEDICATIONS FOR AT LEAST 7 DAYS PRIOR TO TESTING WITH THE EXCEPTION OF ANTACIDS, WHICH MAY BE TAKEN UP UNTIL THE MORNING OF THE VISIT.
- Chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
Key exclusion criteria (19 listed)
- Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
- Prior surgery in the area of the gastroesophageal junction (GEJ), including prior hiatal hernia repair.
- Presence of ˃3 cm hiatal hernia as determined by endoscopy or barium esophagram.
- Subject had any major complications related to the laparoscopic sleeve gastrectomy that may interfere with, or increase the risks of the LINX procedure (such as, but not limited to, leaks from the gastric remnant and infection at the sleeve gastrectomy).
- Plans to surgically revise the gastric pouch (either known preoperatively or decided intraoperatively).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The LINX® Reflux Management SystemAlso: LINX deviceThe LINX device is a permanent implant placed at the area of the lower esophageal sphincter (LES) and is designed to augment a weak LES and minimize or eliminate GERD-related symptoms. | Device | LINX arm |
Primary outcome
Change is GERD-HRQL Score as a measure of efficacy
Time frame: Baseline, 6 month visit
Number of participants with serious complications as a measure of safety.
Time frame: 6 month visit
Change is total distal acid exposure as a measure of efficacy.
Time frame: Baseline, 6 month visit
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The LINX® Reflux Management System in people with GERD and Gastroesophageal Reflux Disease, run by Torax Medical Incorporated at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change is GERD-HRQL Score as a measure of efficacy (time frame: Baseline, 6 month visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.