The purpose of the study is to evaluate the safety and effectiveness of the LINX device in the treatment of GERD
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary safety endpoint:
The primary safety endpoint is the rate of occurrence for serious de-vice and
procedure related adverse events. The primary safety end-point will be assessed
by reporting all adverse events and by esti-mating the rate of serious device
and procedure related adverse events through 12 months post implantation.
Safety will also be evaluated by endoscopy to assess the mucosa and
abdominal/chest X-ray evaluations to verify device location at 12 months post
im-plantation.
Primary effectiveness endpoints:
Reduction in total distal esophageal acid exposure time defined by esophageal
pH testing. Testing will be performed with subjects off PPIs. The subject*s
baseline pH acid exposure time will serve as the control and be compared to the
subject*s pH acid exposure time 12 months post implantation.
Success criteria * At least 60% of subjects will have nor-malized or improved
by at least 50% in total distal acid exposure
Secondary outcome
Secondary effectiveness endpoints:
Subjects GERD-HRQL (Health Related Quality of Life) scores will be assessed off
all GERD medications. The subject*s baseline GERD-HRQL score will serve as the
control and be compared to the sub-ject*s GERD-HRQL 12 months post
implantation.
Success criteria - At least 60% of subjects will have a 50% reduction in total
GERD-HRQL scores
Subject*s average daily dose of PPI will be evaluated. The subject*s baseline
average daily dosage will serve as the control and be com-pared to the
subject*s average daily dosage 12 months post-procedure.
Success criteria - At least 60% of subjects will reduce their average daily PPI
dosage *50%
Number of TLESR's
Background summary
GERD, which manifests mainly as heartburn, regurgitation, or both, is a chronic
disorder associated with substantial morbidity and a major adverse impact on
patient quality of life. In industrialized nations the disease has become
increasingly common, with an estimated prevalence in the general population of
approximately 7%1. The normal physiological barrier to GERD is made up of two
major components: The LES and the diaphragm. A sphincter muscle provides tone
to create a high pressure zone. The LES muscle works in conjunction with the
diaphragm to close the junction between the esophagus and the stomach keeping
acidic contents from refluxing into the esophagus. A competent LES keeps the
esophagus closed to gastric contents and opens during swallowing to allow food
to pass into the stomach. An incompetent LES, however, will open from normal
gastric pressures and allow acidic contents to reflux into the esophagus. An
incompetent LES is the result of a weak muscle that does not have enough tone
to keep the esophagus closed.
Torax Medical, Inc. has designed a device to augment the LES. The device is
designed to be placed on the external esophagus in the region of the (LES). The
implant is comprised of a circumferential series of magnetic beads, where the
attractive force of the magnetic beads provides additional strength to close a
weak LES under normal gastric pressure.
Study objective
The purpose of the study is to evaluate the safety and effectiveness of the
LINX device in the treatment of GERD
Study design
The study is a prospective, multi-center, single arm clinical study that will
be conducted in the United States and Europe.
Approximately 2 years (includes time for enrollment and completion of 60 month
follow-up).
This clinical evaluation will be conducted at up to fifteen (15)
investigational centers. Investigators will be selected among surgeons with
experience performing anti-reflux laparoscopic procedures.
Intervention
At screening and at 12 months post procedure:
Esophageal manometry + pH -impedance test
pH test by Bravo capsule
Endoscopy
Barium swallow
chest x-ray
At 24 and 60 months Endoscopy and chest/abdominal x-ray
Study burden and risks
Risks of LINX device implantation procedure and/or device:
* Achalasia
* Bleeding
* Death
* Device erosion
* Device explant/re-operation
* Device failure
* Device migration (device does not appear to be at implant site)
* Dysphagia
* Inability to belch or vomit
* Infection
* Impaired gastric motility
* Injury to the esophagus, spleen, or stomach
* Organ damage caused by device migration
* Pain
* Peritonitis
* Pneumothorax
* Regurgitation
* Stomach Bloating
* Worsening of preoperative symptoms (including but not lim-ited to dysphagia
or heartburn
14.1 Potential Risks
Complications associated with surgical procedures and device implants have been
compiled from the scientific literature and were identified as anticipated
adverse events. As with any investigational or approved device, a potential
exists for the occurrence of unanticipated ad-verse events. Torax Medical has
no evidence to suggest that the risk of complications asso-ciated with use of
the LINX device is greater than the risks posed by other existing mar-keted
products/procedures except for those potential risks which are unique to the
LINX* device.
Risk
Device migration - up or down esophagus
Device integrity compromised (link breaks)
Device integrity compromised (hermetic seal failed)
Magnetic field in-teraction with elec-trical implant or metallic, abdominal
implants
Toxic Response
Exposure to MRI
Potential Benefits
The potential benefit to subjects being implanted with the LINX device are: to
restore the normal function of the LES; to reduce or eliminate GERD related
symptoms; and to reduce or eliminate dependence on GERD medications.
4188 Lexington Ave. North
MN 55126, Shoreview
US
4188 Lexington Ave. North
MN 55126, Shoreview
US
Listed location countries
Age
Inclusion criteria
Age * 19 years - * 75 years
Suitable surgical candidate
Patient requires daily PPI or other anti-reflux therapy
Total distal Ambulatory Esophageal pH must be * 4.5% of the time * pH4
GERD symptoms in absence of anti-reflux therapy
Subject has signed an ICF
Exclusion criteria
The procedure is an emergency procedure
Patient is currently being treated with another investigational drug or investigational device
Prior gastric esophageal surgery
Any previous endoscopic anti-reflux intervention for GERD and /or previous endoscopic intervention for treatment of Barret's esophagus
Suspected or confirmed esophageal or gastric cancer
Hiatal hernia > 3 cm
Esophageal motility less than 35 mmHg peristaltic amplitude on wet swallows or < 70% (propulsive) peristaltic sequences
Esophagitis grade C-D
Symptoms of dysphagia more than once a week within the last 3 months
Patient diagnosed with scleroderma or achalasia, Nutcracker esophagus
Gross esophageal anatomic abnormalities or esophgeal stricture
Patient is pregnant or nursing or plans to become pregnant
Patient has Barret esophagus
BMI>35
Allergies to titanium, stainless steel, nickel or ferrous materials
Diagnosed psychiatric disorders
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24838.018.08 |