N/A Completed N=44 Treatment

An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

Gastroesophageal Reflux Disease

Source: ClinicalTrials.gov NCT01058070 ↗

Enrolled (actual)

Serious AEs

6.8%

Results posted

Jun 2014

Primary outcomePrimary: To Evaluate the Incidence of All Adverse Events at Various Time Points. — 29 participants

Summary

Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function in the treatment of Gastroesophageal Reflux Disease (GERD)

Outcome Measures

Outcome	Result	p-value
PRIMARY To Evaluate the Incidence of All Adverse Events at Various Time Points.	29	—
PRIMARY To Monitor the Improvement of GERD Symptoms.	93.9	—

Eligibility Criteria

Inclusion Criteria

Age ≥ 18 years, 3yrs.
Documented history of GERD symptoms such as heartburn and/or regurgitation.
On daily PPI treatment for at least 3-months.
Responsive to PPI treatment.
GERD symptoms, in absence of PPI therapy (minimum 10 days).
Ambulatory Esophageal pH 30% failed (non-propulsive) peristaltic sequences.
Patient has esophagitis - Grade B, C, D (LA Classification).
Patient has Barretts Esophagus.
Patient has BMI > 35.
Patient has symptoms of dysphagia or indications of dysphagia from barium esophagram.
Patient has Scleroderma and/or Achalasia.
Patient has an esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, etc.).
Patient has an electrical implant or metallic, abdominal implant(s).
Patient cannot understand trial requirements or is unable to comply with follow-up schedule.
Patient is pregnant or nursing, or plans to become pregnant.
Patient has a psychiatric disorder.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01058070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.