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A Study of Reflux Management With the LINX® System for Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy (RELIEF)

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ClinicalTrials.gov Identifier: NCT02429830
Recruitment Status : Recruiting
First Posted : April 29, 2015
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Torax Medical Incorporated

Brief 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.

Condition or disease Intervention/treatment Phase
GERD Gastroesophageal Reflux Disease Device: LINX device Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RELIEF Study: A Prospective, Multicenter Study of REflux Management With the LINX® System for Gastroesophageal REFlux Disease After Laparoscopic Sleeve Gastrectomy
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Single arm study
Previous LSG patient will be treated with the LINX device and serve as their own control
Device: 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.




Primary Outcome Measures :
  1. Change in GERD-HRQL Score as a measure of efficacy [ Time Frame: 12 month visit ]
    At least 50% reduction in total GERD-HRQL score compared to baseline (off PPIs)

  2. Number of participants with serious complications as a measure of safety [ Time Frame: through 12 months post implant ]
    Safety will be assessed by the rate of (number and percentage of subjects experiencing) device and/or procedure related adverse events after LINX placement

  3. Change in total distal acid exposure as a measure of efficacy [ Time Frame: 12 month visit ]
    Normalization of total distal acid exposure (% total time pH<4) or at least 50% reduction in total distal acid exposure compared to baseline

  4. Change in PPI use as a measure of efficacy [ Time Frame: 12 month visit ]
    At least 50% reduction in average daily PPI dosage compared to baseline



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

Subjects included in the study must meet all the following criteria:

  1. Age >22 years
  2. Laparoscopic sleeve gastrectomy (LSG) for obesity >12 months prior to proposed device implantation date.
  3. Subject is a surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery.
  4. 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).
  5. Subject requires daily proton pump inhibitor or other anti-reflux drug therapy.
  6. 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.
  7. 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.
  8. GERD symptoms, in absence of PPI therapy (minimum 7 days).
  9. 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.
  10. Subject is willing and able to cooperate with follow-up examinations
  11. Subject has been informed of the study procedures and the treatment and has signed an informed consent form.

EXCLUSION CRITERIA

Subjects should be excluded from the study based on the following criteria:

  1. The procedure is an emergency procedure.
  2. Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
  3. Presence of ˃3 cm hiatal hernia as determined by endoscopy or barium esophagram.
  4. 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)
  5. Plans to surgically revise the gastric pouch (either known preoperatively or decided intraoperatively)
  6. Currently being treated with another investigational drug or investigational device.
  7. Suspected or confirmed esophageal or gastric cancer or prior gastric or esophageal surgery or endoscopic intervention for GERD (with the exception of sleeve gastrectomy).
  8. 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).
  9. Presence of esophagitis - Grade C or D (LA Classification).
  10. BMI >35.
  11. Symptoms of dysphagia more than once per week within the last 3 months.
  12. Diagnosed with Scleroderma.
  13. Diagnosed with an esophageal motility disorder such as but not limited to achalasia, nutcracker esophagus, or diffuse esophageal spasm or hypertensive LES.
  14. Subject has a history of or known esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.)
  15. Subject has esophageal or gastric varices
  16. 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
  17. Subject cannot understand trial requirements or is unable to comply with follow-up schedule
  18. Pregnant or nursing, or plans to become pregnant during the course of the study.
  19. Any reason which the Investigator believes may cause the subject to be non-compliant with or unable to meet the protocol requirements.
  20. Subject has an electrical implant or metallic, abdominal implants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429830


Contacts
Contact: Kari Loing 651-361-8900 kloing@toraxmedical.com
Contact: Caitlin Monette 651-361-8900 cmonette@toraxmedical.com

Locations
United States, Arizona
Southern Arizona Centers for Minimally Invasive Surgery Recruiting
Tucson, Arizona, United States, 85741
Contact: Patrick Chiasson, MD    520-219-8690    pmchiasson@gmail.com   
Principal Investigator: Patrick Chiasson, MD         
Sub-Investigator: Stephen Burpee, MD         
United States, Arkansas
Mercy Health Northwest Arkansas Recruiting
Rogers, Arkansas, United States, 72758
Contact: Laura Canter    479-338-3004    Laura.Canter@Mercy.Net   
Principal Investigator: Philip Woodworth, MD         
United States, Louisiana
Surgical Specialists of Louisiana Recruiting
Metairie, Louisiana, United States, 70001
Contact: Jennifer Perilloux    504-934-3000 ext 2345    jperilloux@Whyweight.com   
Principal Investigator: James Redmann, MD, FACS         
Sub-Investigator: Michael Thomas, MD         
Sub-Investigator: Clark Warden, MD         
United States, New York
Adirondack Surgical Group Recruiting
Saranac Lake, New York, United States, 12983
Contact: Nikki Patraw    518-891-1610    asgnpatraw@gmail.com   
Principal Investigator: Michael Hill, MD         
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Christina Seafler, RN    216-844-4706    christina.seafler@uhhospitals.org   
Principal Investigator: Leena Khaitan, MD         
United States, South Carolina
Coastal Carolina Bariatric & Surgical Center Recruiting
Summerville, South Carolina, United States, 29485
Contact: Ella "Recci" Rock, NPC    843-875-8994    Ella.Rock@hcahealthcare.com   
Principal Investigator: Michael Michel, MD         
Sponsors and Collaborators
Torax Medical Incorporated

Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT02429830     History of Changes
Other Study ID Numbers: 4600
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At study completion

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Torax Medical Incorporated:
gastroesophageal reflux disease
GERD
obesity
LSG
Laparoscopic Sleeve Gastrectomy

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases