GERDRELIEFNCT02429830
LINX Reflux Management System in Subjects With GERD Who Have Previously Undergone a Laparoscopic Sleeve Gastrectomy
A study testing LINX device in people with GERD and Gastroesophageal Reflux Disease, run by Torax Medical Incorporated at 12 sites in United States.
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 22 years and older
- Conditions the study is for
- GERD, Gastroesophageal Reflux Disease
- What is being tested?
- LINX device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 12 sitesUnited States
- Study dates
- 5 Apr 2017to 8 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects included in the study must meet all the following criteria:
- Age >22 years
- Laparoscopic sleeve gastrectomy (LSG) for obesity >12 months prior to proposed device implantation date.
- Subject is a surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery.
- Documented typical symptoms of GERD for longer than 6 months (regurgitation or heartburn which is defined as a burning epigastric or substernal pain which responds to acid neutralization or suppression).
- Subject requires daily proton pump inhibitor or other anti-reflux drug therapy.
Show all 12Show fewer
- Total distal ambulatory esophageal pH must meet the following criteria: pH <4 for >4.5% of the time. Note: Subjects shall have discontinued any GERD medications for at least 7 days prior to testing, with the exception of antacids up to the morning of testing.
- Subjects with symptomatic improvement on PPI therapy demonstrated by a GERD-HRQL score of <10 on PPI and >15 off PPI, or subjects with a >6 point improvement when comparing their on PPI and off PPI GERD-HRQL scores.
- GERD symptoms, in absence of PPI therapy (minimum 7 days).
- If the subject is of child bearing potential must have a negative pregnancy test within one week prior to implant and must agree to use effective means of birth control during the course of the study.
- Subject is willing and able to cooperate with follow-up examinations
- Subject has been informed of the study procedures and the treatment and has signed an informed consent form.
Who cannot join
- Subjects should be excluded from the study based on the following criteria:
- The procedure is an emergency procedure.
- Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
- 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)
Show all 24Show fewer
- Currently being treated with another investigational drug or investigational device.
- 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 (if using Conventional Manometry). -or- If using High Resolution Manometry (exclude for any of the following):
- Distal Contractile Integral (DCI) ≤ 450 mmHg·s·cm or
- ≥ 50% ineffective swallows or
- ≥ 50% fragmented swallows (Fragmented swallows are defined as those with a ≥ 5cm break [large] in peristaltic integrity).
- 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.
- Subject has a history of or known esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.)
- Subject has esophageal or gastric varices
- History of/or known Barrett's esophagus. Note: The diagnosis of Barrett's esophagus requires both endoscopic and histologic evidence of metaplastic columnar epithelium. Endoscopically, there must be columnar epithelium within the esophagus. Histologically, the epithelium must be metaplastic, as defined by the presence of goblet cells.by
- Subject 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.
- Subject has an electrical implant or metallic, abdominal implants.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Panhandle Weight Loss Center
Amarillo, Texas, 79106
Buffalo General Medical Center
Buffalo, New York, 14203
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, 80113
East Carolina University
Greenville, North Carolina, 27834
Gunderson Health System
La Crosse, Wisconsin, 54601
Keck Medical Center of USC
Los Angeles, California, 90033
Mercy Health Northwest Arkansas
Rogers, Arkansas, 72758
Adirondack Surgical Group
Saranac Lake, New York, 12983
RWJBH Univ. Hospital Somerset/Advanced Surgical and Bariatrics of NJ, PA
Somerset, New Jersey, 08873
Coastal Carolina Bariatric & Surgical Center
Summerville, South Carolina, 29485
Northwest Allied Bariatric & Foregut Surgery
Tucson, Arizona, 85741
About this study
Official title: A Prospective, Multicenter Study of REflux Management 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.
Read the detailed description
The objective of this study is to confirm safety and efficacy after laparoscopic sleeve gastrectomy (LSG) in subjects indicated for LINX is similar to the outcomes that formed the basis for the LINX Premarket Approval to support modification of the current labeling. Presently, there is a precautionary statement that safety and effectiveness of the LINX has not been established for prior esophageal or gastric surgery or endoscopic intervention.
Patients with GERD that have undergone a LSG procedure have limited surgical treatment options if they are looking for an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent). One procedure, fundoplication, is extremely difficult to perform as LSG patients have a limited amount of fundus tissue remaining after sleeve surgery. Roux-en-Y gastric bypass (RYGB) may be chosen as a conversion procedure but is more invasive with the potential for serious complications. LINX may be considered as an alternative and less invasive option that may potentially have few complications compared to RYGB.
The study is an observational, multicenter, single-arm study with prospective enrollment. Based on the observational status of the study, no formal statistical hypothesis tests will be conducted. Up to 30 patients meeting the eligibility requirements will be implanted with LINX and followed through 12-months after implant. Up to twelve (12) clinical sites will enroll subjects. Safety evaluations will be ongoing throughout the duration of the study, starting at the implant procedure. Efficacy endpoints will be evaluated at the 12-month visit.
Safety will be evaluated based on the rate of serious device and procedure related adverse events (AEs). Safety will also be evaluated by endoscopy to assess the mucosa and x-rays to verify device location at 12 months post implant. Efficacy will be measured at 12 months (compared to baseline) by examining 3 variables: normalization of total distal acid exposure or at least a 50% reduction, at least a 50% reduction in total GERD-HRQL scores and at least a 50% reduction in average daily PPI dosage.
- Conditions
- GERD, Gastroesophageal Reflux Disease
- Being tested
- LINX device
- Keywords
- gastroesophageal reflux disease, GERD, obesity, LSG, Laparoscopic Sleeve Gastrectomy
- 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.
LINX deviceDevice
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 |
|---|---|---|
| Single arm study | Other | Previous LSG patient will be treated with the LINX device and serve as their own control Receives: Device: LINX device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Reporting Greater Than or Equal to (>=) 50 Percent (%) Reduction in Total Gastroesophageal Reflux Disease (GERD)- Health-Related Quality of Life (HRQL) Score Compared to Baseline (Off GERD Medications) at the 12-month Follow-up
Percentage of participants reporting >=50% reduction in total GERD-HRQL score compared to baseline (off GERD Medications) at the 12-month follow-up were reported. The GERD-HRQL score consisted of 10 questions, where participants were required to answer each question on a scale of 0 to 5 (0: no symptoms; 1: symptoms noticeable but not bothersome; 2: symptoms noticeable and bothersome but not every day; 3: symptoms bothersome every day; 4: symptoms affect daily activity; 5: symptoms are incapacitating, unable to do activities). The total score was derived by simply adding the individual score of each question. The total score ranged from 0 to 50 where a higher score indicated more severe disease. The best possible total GERD-HRQL score was 0 (asymptomatic in all questions) and the worst possible score was 50 (incapacitated in all questions).
Measured: Up to 12 Months
Percentage of Participants Reporting Normalization of Total Distal Acid Exposure Time or at Least a 50% Reduction in Total Distal Acid Exposure Time Compared to Baseline at the 12-month Follow-up
Percentage of participants reporting normalization of total distal acid exposure time or at least a 50% reduction in total distal acid at the 12-month follow-up were reported. The testing was performed by a reflux sensing implantable capsule (for example, Bravo) or via a trans-nasal catheter. Success of the LINX device in decreasing abnormal levels of gastric acid in the esophagus was defined as normalization of distal acid exposure time (pH less than [<] 4 for greater than or equal to [>=] 4.5% of monitoring time) or at least 50% reduction in distal acid exposure time compared to baseline.
Measured: Up to 12 months
Percentage of Participants Reporting >=50% Reduction in Average Daily Protocol Pump Inhibitors (PPIs) Dosage Compared to Baseline at the 12-month Follow-up
Percentage of participants reporting >=50% reduction in average daily protocol pump inhibitors (PPIs) dosage compared to baseline at the 12-month follow-up were reported.
Measured: Up to 12 months
Number of Participants Experiencing Serious Device and/or Procedure Related Adverse Events After LINX Placement Out to 12 Months
Number of participants experiencing serious device and/or procedure related adverse events after LINX placement out to 12 months were reported. SAE is any AE that results in: requires subject hospitalization greater than (>) 24 hours; is life-threatening or results in death; requires prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; results in fetal distress, fetal death, or a congenital anomaly or birth defect; requires intervention to prevent permanent impairment or damage of body function or structure; other serious important medical events that do not fit in the other outcomes and may jeopardize the participant and may require medical or surgical intervention to prevent one of the other outcomes.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study start5 Apr 2017
- Primary completion8 Jun 2021
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torax Medical Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William J. Petraiuolo, MD, Study director, Ethicon Endo-Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429830
- Sponsor's protocol ID
- 4600
- Other IDs
- TRX_2016_01
- Acronym
- RELIEF
- Status last verified
- Aug 2022
- First submitted
- 13 Apr 2015
- Last updated
- 10 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study of REflux Management With the LINX® System for Gastroesophageal REFlux Disease After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02429830
- Acronym / sponsor ID
- RELIEF / 4600
- Conditions
- GERD, Gastroesophageal Reflux Disease
- Keywords
- gastroesophageal reflux disease, GERD, obesity, LSG, Laparoscopic Sleeve Gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Torax Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Posted 5 Jul 2022
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.
Detailed description
The objective of this study is to confirm safety and efficacy after laparoscopic sleeve gastrectomy (LSG) in subjects indicated for LINX is similar to the outcomes that formed the basis for the LINX Premarket Approval to support modification of the current labeling. Presently, there is a precautionary statement that safety and effectiveness of the LINX has not been established for prior esophageal or gastric surgery or endoscopic intervention.
Patients with GERD that have undergone a LSG procedure have limited surgical treatment options if they are looking for an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent). One procedure, fundoplication, is extremely difficult to perform as LSG patients have a limited amount of fundus tissue remaining after sleeve surgery. Roux-en-Y gastric bypass (RYGB) may be chosen as a conversion procedure but is more invasive with the potential for serious complications. LINX may be considered as an alternative and less invasive option that may potentially have few complications compared to RYGB.
The study is an observational, multicenter, single-arm study with prospective enrollment. Based on the observational status of the study, no formal statistical hypothesis tests will be conducted. Up to 30 patients meeting the eligibility requirements will be implanted with LINX and followed through 12-months after implant. Up to twelve (12) clinical sites will enroll subjects. Safety evaluations will be ongoing throughout the duration of the study, starting at the implant procedure. Efficacy endpoints will be evaluated at the 12-month visit.
Safety will be evaluated based on the rate of serious device and procedure related adverse events (AEs). Safety will also be evaluated by endoscopy to assess the mucosa and x-rays to verify device location at 12 months post implant. Efficacy will be measured at 12 months (compared to baseline) by examining 3 variables: normalization of total distal acid exposure or at least a 50% reduction, at least a 50% reduction in total GERD-HRQL scores and at least a 50% reduction in average daily PPI dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Device: LINX devicePrevious LSG patient will be treated with the LINX device and serve as their own control |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age >22 years
- Laparoscopic sleeve gastrectomy (LSG) for obesity >12 months prior to proposed device implantation date.
- Subject is a surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery.
- Documented typical symptoms of GERD for longer than 6 months (regurgitation or heartburn which is defined as a burning epigastric or substernal pain which responds to acid neutralization or suppression).
- Subject requires daily proton pump inhibitor or other anti-reflux drug therapy.
Key exclusion criteria (24 listed)
- The procedure is an emergency procedure.
- Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
- 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 |
|---|---|---|
| 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 | Single arm study |
Primary outcome
Percentage of Participants Reporting Greater Than or Equal to (>=) 50 Percent (%) Reduction in Total Gastroesophageal Reflux Disease (GERD)- Health-Related Quality of Life (HRQL) Score Compared to Baseline (Off GERD Medications) at the 12-month Follow-up
Time frame: Up to 12 Months
Percentage of participants reporting >=50% reduction in total GERD-HRQL score compared to baseline (off GERD Medications) at the 12-month follow-up were reported. The GERD-HRQL score consisted of 10 questions, where participants were required to answer each question on a scale of 0 to 5 (0: no symptoms; 1: symptoms noticeable but not bothersome; 2: symptoms noticeable and bothersome but not every day; 3: symptoms bothersome every day; 4: symptoms affect daily activity; 5: symptoms are incapacitating, unable to do activities). The total score was derived by simply adding the individual score of each question. The total score ranged from 0 to 50 where a higher score indicated more severe disease. The best possible total GERD-HRQL score was 0 (asymptomatic in all questions) and the worst possible score was 50 (incapacitated in all questions).
Percentage of Participants Reporting Normalization of Total Distal Acid Exposure Time or at Least a 50% Reduction in Total Distal Acid Exposure Time Compared to Baseline at the 12-month Follow-up
Time frame: Up to 12 months
Percentage of participants reporting normalization of total distal acid exposure time or at least a 50% reduction in total distal acid at the 12-month follow-up were reported. The testing was performed by a reflux sensing implantable capsule (for example, Bravo) or via a trans-nasal catheter. Success of the LINX device in decreasing abnormal levels of gastric acid in the esophagus was defined as normalization of distal acid exposure time (pH less than [<] 4 for greater than or equal to [>=] 4.5% of monitoring time) or at least 50% reduction in distal acid exposure time compared to baseline.
Percentage of Participants Reporting >=50% Reduction in Average Daily Protocol Pump Inhibitors (PPIs) Dosage Compared to Baseline at the 12-month Follow-up
Time frame: Up to 12 months
Percentage of participants reporting >=50% reduction in average daily protocol pump inhibitors (PPIs) dosage compared to baseline at the 12-month follow-up were reported.
Number of Participants Experiencing Serious Device and/or Procedure Related Adverse Events After LINX Placement Out to 12 Months
Time frame: Up to 12 months
Number of participants experiencing serious device and/or procedure related adverse events after LINX placement out to 12 months were reported. SAE is any AE that results in: requires subject hospitalization greater than (>) 24 hours; is life-threatening or results in death; requires prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; results in fetal distress, fetal death, or a congenital anomaly or birth defect; requires intervention to prevent permanent impairment or damage of body function or structure; other serious important medical events that do not fit in the other outcomes and may jeopardize the participant and may require medical or surgical intervention to prevent one of the other outcomes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
William J. Petraiuolo, MD study director
Ethicon Endo-Surgery
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LINX device in people with GERD and Gastroesophageal Reflux Disease, run by Torax Medical Incorporated at 12 sites in United States.
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 12 inclusion and 24 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: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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?
Yes. Results are posted in the registry (first posted 5 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Reporting Greater Than or Equal to (>=) 50 Percent (%) Reduction in Total Gastroesophageal Reflux Disease (GERD)- Health-Related Quality of Life (HRQL) Score Compared to Baseline (Off GERD Medications) at the 12-month Follow-up (time frame: Up to 12 Months). The study lists 4 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 10 Aug 2022.