Trial Outcomes & Findings for LINX Reflux Management System Clinical Study Protocol (NCT NCT00776997)

Last Updated: 2018-05-04

Results Overview

SAE was defined as any untoward medical occurrence, whether related to the study device or procedure or not, that meets one or more of the following criteria: * Results in death * Is life-threatening * Requires subject hospitalization \> 24 hours * 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. Outcome measure reports number of subjects with reported events.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

through 24 months

Results posted on

2018-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	LINX System All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
Overall Study STARTED	100
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	LINX System All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
Overall Study Adverse Event	2

Baseline Characteristics

LINX Reflux Management System Clinical Study Protocol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LINX System n=100 Participants All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	50.4 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Region of Enrollment United States	96 participants n=5 Participants
Region of Enrollment Netherlands	4 participants n=5 Participants
Percentage of total monitoring time esophageal pH <4	11.6 Percentage of total monitoring time STANDARD_DEVIATION 4.7 • n=5 Participants
Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) total score	26.6 Total Score STANDARD_DEVIATION 6.6 • n=5 Participants
Use of daily proton-pump inhibitors (PPIs)	100 participants n=5 Participants
Years of proton-pump inhibitor use	6.3 years STANDARD_DEVIATION 4.8 • n=5 Participants

PRIMARY outcome

Timeframe: through 24 months

Outcome measures

Outcome measures
Measure	LINX System n=100 Participants All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs).	6 participants

PRIMARY outcome

Timeframe: 12 Months

The analysis cohort for the primary efficacy analysis was the treated population which includes all implanted subjects and was determined through esophageal pH testing.

Outcome measures

Outcome measures
Measure	LINX System n=100 Participants All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
Normalization of Esophageal Acid Exposure Time or Reduced Total Acid Exposure Time of at Least 50% Compared to the Subject's Baseline Measurement by Esophageal pH Testing.	64 participants 4.8

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	LINX System n=100 Participants All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline	92 participants 5.4

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	LINX System n=100 Participants All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline	93 participants

Adverse Events

LINX System

Serious events: 6 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LINX System n=100 participants at risk All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
Gastrointestinal disorders Dysphagia	3.0% 3/100 • Number of events 3
Gastrointestinal disorders Nausea	2.0% 2/100 • Number of events 2
Gastrointestinal disorders Odynophagia	1.0% 1/100 • Number of events 1
Gastrointestinal disorders Vomiting	2.0% 2/100 • Number of events 2
General disorders Pain	1.0% 1/100 • Number of events 1

Other adverse events

Other adverse events
Measure	LINX System n=100 participants at risk All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
Gastrointestinal disorders Dysphagia	68.0% 68/100 • Number of events 76
General disorders Pain	24.0% 24/100 • Number of events 25
Gastrointestinal disorders Stomach Bloating	14.0% 14/100 • Number of events 15
Gastrointestinal disorders Nausea	7.0% 7/100 • Number of events 8
Gastrointestinal disorders Odynophagia	8.0% 8/100 • Number of events 8
General disorders Hiccups	8.0% 8/100 • Number of events 8
Gastrointestinal disorders Inability to belch or vomit	6.0% 6/100 • Number of events 6

Additional Information

Amy Derosier, VP of Clinical Affairs

Torax Medical

Phone: 651-361-8900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60