Trial Outcomes & Findings for An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter (NCT NCT01058070)

NCT ID: NCT01058070

Last Updated: 2021-02-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2021-02-01

Participant Flow

Participant milestones

Measure	Implantable Device Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
Overall Study STARTED	44
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

Baseline characteristics by cohort

Measure	Implantable Device n=44 Participants Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
Age, Continuous	42.8 years n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	26 Participants n=93 Participants
Body Mass Index (BMI)	25.7 kg/m^2 n=93 Participants
% time esophageal pH<4	11.9 percentage n=93 Participants
Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL)	26.5 scores on a scale n=93 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Measure	LINX Study Subjects n=44 Participants Subjects implanted with LINX device
To Evaluate the Incidence of All Adverse Events at Various Time Points.	29 participants

PRIMARY outcome

Timeframe: 5 years

Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms

Outcome measures

Measure	LINX Study Subjects n=33 Participants Subjects implanted with LINX device
To Monitor the Improvement of GERD Symptoms.	93.9 percentage of participants

Adverse Events

Implantable Device

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Implantable Device n=44 participants at risk Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
Gastrointestinal disorders Vomiting & Nausea	2.3% 1/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.
Gastrointestinal disorders Dysphagia	2.3% 1/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.
General disorders Chest Pain	2.3% 1/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.

Other adverse events

Measure	Implantable Device n=44 participants at risk Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
Gastrointestinal disorders Dysphagia	45.5% 20/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.
Gastrointestinal disorders Vomiting & Nausea	2.3% 1/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.
General disorders Pain	6.8% 3/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.
Surgical and medical procedures Device explant/reoperation	2.3% 1/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.
Gastrointestinal disorders Stomach bloating	4.5% 2/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.
General disorders No improvement	6.8% 3/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.
Gastrointestinal disorders Inability to belch or vomit	4.5% 2/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.
Gastrointestinal disorders Heartburn	4.5% 2/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.
Gastrointestinal disorders Abdominal Pain	6.8% 3/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.
Gastrointestinal disorders Nausea	6.8% 3/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.
Gastrointestinal disorders Vomiting	6.8% 3/44 • Pre-discharge, 2-Weeks, 6-Weeks, 3-Months, 6-Months, 12-Months, 18-Months, 24-Months, 30-Months, 36-Months, 42-Months, 48-Months, 54-Months, and 60-Months Follow-up An adverse event (AE) is any undesirable/unusual experience that occurs to a subject during the clinical study, whether or not considered device related, including, (but not limited to) those events that result from the use as stipulated in the protocol.

Additional Information

VP of Clinical Affairs

Torax Medical, Inc.

Phone: 651-361-8900

Email: aderosier@toraxmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER