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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02429830
Recruitment Status : Recruiting
First Posted : April 29, 2015
Last Update Posted : November 13, 2019
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

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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 : December 31, 2021
Estimated Study Completion Date : December 31, 2021

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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Contact: Kari Loing 651-361-8900 kloing@its.jnj.com

Locations
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United States, Arizona
Northwest Allied Bariatric & Foregut Surgery Recruiting
Tucson, Arizona, United States, 85741
Contact: Rachel Deal, RD    520-219-8690    Rachel.Deal@northwestmedicalcenter.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, California
Keck Medical Center of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Michelle Hernandez    323-442-6252    Michelle.Hernandez@med.usc.edu   
Contact: Pui Yan    323-442-5693    puiyan@med.usc.edu   
Principal Investigator: Caitlin Houghton, MD         
Sub-Investigator: Kulmeet Sandhu, MD         
Sub-Investigator: John Lipham, MD         
United States, Colorado
Institute of Esophageal and Reflux Surgery Recruiting
Englewood, Colorado, United States, 80113
Contact: Rachel Heidrick, RN    303-788-7700    rachel@iersurgery.com   
Sub-Investigator: Reginald Bell, MD         
Principal Investigator: Jocelyn Burke, MD         
Sub-Investigator: Kate Freeman, NP         
United States, Louisiana
Surgical Specialists of Louisiana Withdrawn
Metairie, Louisiana, United States, 70001
United States, New Jersey
RWJBH Univ. Hospital Somerset/Advanced Surgical and Bariatrics of NJ, PA Recruiting
Somerset, New Jersey, United States, 08873
Contact: Andrew Wassef, PhD    732-640-5327 ext 115    andreww@advancedsab.com   
Principal Investigator: Ragui Sadek, MD         
United States, New York
Buffalo General Medical Center Recruiting
Buffalo, New York, United States, 14203
Contact    716-859-1168      
Principal Investigator: Aaron Hoffman, MD         
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, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Jennifer Bremer       bremerj17@ecu.edu   
Principal Investigator: Carlos Anciano, MD         
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Nancy Furey, RN    216-844-7314    nancy.furey@uhhospitals.org   
Principal Investigator: Leena Khaitan, MD         
United States, South Carolina
Coastal Carolina Bariatric & Surgical Center Recruiting
Summerville, South Carolina, United States, 29485
Contact: Diana Axiotix, PA-C    843-875-8994      
Principal Investigator: Michael Michel, MD         
United States, Texas
Panhandle Weight Loss Center Recruiting
Amarillo, Texas, United States, 79106
Contact: Amy Thompson       athompson@pnpresearch.net   
Principal Investigator: Darren Peterson, MD         
United States, Wisconsin
Gunderson Health System Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Kim Halverson    608-775-0852      
Principal Investigator: Brandon Grover, DO         
Sponsors and Collaborators
Torax Medical Incorporated

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Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT02429830    
Other Study ID Numbers: 4600
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At study completion

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Torax Medical Incorporated:
gastroesophageal reflux disease
GERD
obesity
LSG
Laparoscopic Sleeve Gastrectomy
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases