LINX Reflux Management System Clinical Study Protocol

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Torax Medical Incorporated

ClinicalTrials.gov Identifier:

NCT00776997

First received: October 20, 2008

Last updated: November 22, 2013

Last verified: November 2013

History of Changes

Results First Received: April 25, 2012

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Gastroesophageal Reflux
Intervention:	Device: Magnetic Sphincter Augmentation

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	LINX System
STARTED	100
COMPLETED	98 ^[1]
NOT COMPLETED	2
Adverse Event	2

^[1]	98 subjects evaluated at 12-months. Endpoint analysis based on all subjects treated (n=100)

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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.

Baseline Measures

LINX System

Overall Participants Analyzed
[Units: Participants]

100

Age
[Units: Participants]

<=18 years

Between 18 and 65 years

>=65 years

Age
[Units: Years]
Mean (Standard Deviation)

50.4 (12.4)

Gender
[Units: Participants]

Female

Male

Region of Enrollment
[Units: Participants]

United States

Netherlands

Total percentage of monitoring time esophageal pH <4 ^[1]
[Units: Percent of time pH<4]
Mean (Standard Deviation)

11.6 (4.7)

^[1]	At baseline, all subjects were evaluated with esophageal pH monitoring with GERD medications discontinued for at least 7 days using the BRAVO System

Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) total score ^[1]
[Units: Total Score]
Mean (Standard Deviation)

26.6 (6.6)

^[1]

The GERD-HRQL scale was administered at baseline with GERD medications discontinued for at least seven days. GERD-HRQL scale objectively quantifies symptom severity. The GERD-HRQL scale consists of 10 questions with the following Responses Scale:

0 = No Symptoms

= Symptoms noticeable, but not bothersome
= Symptoms noticeable and bothersome, but not every day
= Symptoms bothersome every day
= Symptoms affect daily activities
= Symptoms are incapacitating, unable to do daily activities

The worst possible score is 50 based on a response of "5" to all 10 questions.

Use of daily proton-pump inhibitors (PPIs) ^[1]
[Units: Participants]

100

^[1]	At time of enrollment, all medications used by a subject were documented.

Years of proton-pump inhibitor use
[Units: Years]
Mean (Standard Deviation)

6.3 (4.8)

Outcome Measures

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1. Primary:

Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs). [ Time Frame: through 24 months ]

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2. Primary:

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. [ Time Frame: 12 Months ]

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3. Secondary:

At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline [ Time Frame: 12 months ]

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4. Secondary:

Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline [ Time Frame: 12 months ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Amy Derosier, VP of Clinical Affairs
Organization: Torax Medical
phone: 651-361-8900
e-mail: aderosier@toraxmedical.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ganz RA, Edmundowicz SA, Taiganides PA, Lipham JC, Smith CD, DeVault KR, Horgan S, Jacobsen G, Luketich JD, Smith CC, Schlack-Haerer SC, Kothari SN, Dunst CM, Watson TJ, Peters J, Oelschlager BK, Perry KA, Melvin S, Bemelman WA, Smout AJ, Dunn D. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Clin Gastroenterol Hepatol. 2016 May;14(5):671-7. doi: 10.1016/j.cgh.2015.05.028. Epub 2015 Jun 2.

Ganz RA, Peters JH, Horgan S, Bemelman WA, Dunst CM, Edmundowicz SA, Lipham JC, Luketich JD, Melvin WS, Oelschlager BK, Schlack-Haerer SC, Smith CD, Smith CC, Dunn D, Taiganides PA. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. 2013 Feb 21;368(8):719-27. doi: 10.1056/NEJMoa1205544.

Responsible Party:	Torax Medical Incorporated
ClinicalTrials.gov Identifier:	NCT00776997 History of Changes
Other Study ID Numbers:	1802
Study First Received:	October 20, 2008
Results First Received:	April 25, 2012
Last Updated:	November 22, 2013

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