Trial Outcomes & Findings for LINX Reflux Management System in Subjects With GERD Who Have Previously Undergone a Laparoscopic Sleeve Gastrectomy (NCT NCT02429830)
NCT ID: NCT02429830
Last Updated: 2022-08-10
Results Overview
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).
COMPLETED
NA
30 participants
Up to 12 Months
2022-08-10
Participant Flow
Participant milestones
| Measure |
LINX Device
Participants with gastroesophageal reflux disease (GERD) who previously underwent a laparoscopic sleeve gastrectomy were treated with the LINX Reflux Management System, a laparoscopic, fundic-sparing anti-reflux device designed to augment a weak lower esophageal sphincter (LES) and minimize or eliminate GERD-related symptoms.
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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27
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
LINX Device
Participants with gastroesophageal reflux disease (GERD) who previously underwent a laparoscopic sleeve gastrectomy were treated with the LINX Reflux Management System, a laparoscopic, fundic-sparing anti-reflux device designed to augment a weak lower esophageal sphincter (LES) and minimize or eliminate GERD-related symptoms.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Overall Study
Device Explant
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2
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Baseline Characteristics
LINX Reflux Management System in Subjects With GERD Who Have Previously Undergone a Laparoscopic Sleeve Gastrectomy
Baseline characteristics by cohort
| Measure |
LINX Device
n=30 Participants
Participants with gastroesophageal reflux disease (GERD) who previously underwent a laparoscopic sleeve gastrectomy were treated with the LINX Reflux Management System, a laparoscopic, fundic-sparing anti-reflux device designed to augment a weak lower esophageal sphincter (LES) and minimize or eliminate GERD-related symptoms.
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|---|---|
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Age, Continuous
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47.1 years
STANDARD_DEVIATION 12.1 • n=99 Participants
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Sex: Female, Male
Female
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27 Participants
n=99 Participants
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Sex: Female, Male
Male
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3 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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28 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=99 Participants
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Race (NIH/OMB)
White
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27 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Up to 12 MonthsPopulation: The Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure.
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).
Outcome measures
| Measure |
LINX Device
n=26 Participants
Participants with gastroesophageal reflux disease (GERD) who previously underwent a laparoscopic sleeve gastrectomy were treated with the LINX Reflux Management System, a laparoscopic, fundic-sparing anti-reflux device designed to augment a weak lower esophageal sphincter (LES) and minimize or eliminate GERD-related symptoms.
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|---|---|
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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
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80.8 Percentage of participants
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PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The FAS consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
LINX Device
n=27 Participants
Participants with gastroesophageal reflux disease (GERD) who previously underwent a laparoscopic sleeve gastrectomy were treated with the LINX Reflux Management System, a laparoscopic, fundic-sparing anti-reflux device designed to augment a weak lower esophageal sphincter (LES) and minimize or eliminate GERD-related symptoms.
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|---|---|
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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
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44.4 Percentage of participants
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PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The FAS consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
LINX Device
n=24 Participants
Participants with gastroesophageal reflux disease (GERD) who previously underwent a laparoscopic sleeve gastrectomy were treated with the LINX Reflux Management System, a laparoscopic, fundic-sparing anti-reflux device designed to augment a weak lower esophageal sphincter (LES) and minimize or eliminate GERD-related symptoms.
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|---|---|
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Percentage of Participants Reporting >=50% Reduction in Average Daily Protocol Pump Inhibitors (PPIs) Dosage Compared to Baseline at the 12-month Follow-up
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95.8 Percentage of participants
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PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The FAS consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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.
Outcome measures
| Measure |
LINX Device
n=30 Participants
Participants with gastroesophageal reflux disease (GERD) who previously underwent a laparoscopic sleeve gastrectomy were treated with the LINX Reflux Management System, a laparoscopic, fundic-sparing anti-reflux device designed to augment a weak lower esophageal sphincter (LES) and minimize or eliminate GERD-related symptoms.
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|---|---|
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Number of Participants Experiencing Serious Device and/or Procedure Related Adverse Events After LINX Placement Out to 12 Months
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2 Participants
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Adverse Events
LINX Device
Serious adverse events
| Measure |
LINX Device
n=30 participants at risk
Participants with gastroesophageal reflux disease (GERD) who previously underwent a laparoscopic sleeve gastrectomy were treated with the LINX Reflux Management System, a laparoscopic, fundic-sparing anti-reflux device designed to augment a weak lower esophageal sphincter (LES) and minimize or eliminate GERD-related symptoms.
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|---|---|
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Gastrointestinal disorders
Dysphagia
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Surgical and medical procedures
Pain
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Other adverse events
| Measure |
LINX Device
n=30 participants at risk
Participants with gastroesophageal reflux disease (GERD) who previously underwent a laparoscopic sleeve gastrectomy were treated with the LINX Reflux Management System, a laparoscopic, fundic-sparing anti-reflux device designed to augment a weak lower esophageal sphincter (LES) and minimize or eliminate GERD-related symptoms.
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|---|---|
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General disorders
Vomiting, pain in chest and nausea
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Gastrointestinal disorders
Dysphagia
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16.7%
5/30 • Number of events 5 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Surgical and medical procedures
Pain
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10.0%
3/30 • Number of events 3 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Gastrointestinal disorders
Nausea
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6.7%
2/30 • Number of events 2 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Gastrointestinal disorders
Diarrhea
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Gastrointestinal disorders
Esophageal spasm
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Respiratory, thoracic and mediastinal disorders
Pneumothorax
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Gastrointestinal disorders
Epigastric pain and bloating
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Gastrointestinal disorders
Esophagitis
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Skin and subcutaneous tissue disorders
Face tingling and pain
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Respiratory, thoracic and mediastinal disorders
Foam pooling in throat
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Skin and subcutaneous tissue disorders
Hypersensitivity to Dermabond
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Respiratory, thoracic and mediastinal disorders
Pleural effusion
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
|
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Respiratory, thoracic and mediastinal disorders
Post-Op Atelectasis & pleural effusion
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3.3%
1/30 • Number of events 1 • Up to 12 months
Full Analysis Set (FAS) consisted of participants who met all eligibility criteria, provided informed consent, completed baseline assessments, and underwent a LINX procedure.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the Sponsor for the purposes of performing the study, will be published or passed on to any third party without the written consent of Sponsor. Any Investigator involved with this study is obligated to provide the Sponsor with complete test results and all data derived from the study.
- Publication restrictions are in place
Restriction type: OTHER