External UES Band (Shaker Pressure Band) and GERD

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05697393
Status
Recruiting

Conditions

  • Gastroesophageal Reflux

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Shaker Pressure Band — DEVICE

Study Details

This protocol is a study to assess the efficacy of an external upper esophageal band to decrease subjective nighttime symptoms related to esophageal reflux into the pharynx.

Key Dates

Start date
Jan 25, 2011
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Shaker Pressure Band GERD patients with external laryngeal pressure
    One week of Shaker pressure band
  • Placebo Comparator: Shaker Pressure Band GERD patients without external laryngeal pressure
    One week of sham Shaker pressure band (no external laryngeal pressure)

Primary Outcome Measure

Symptom Analysis [ Time Frame: Initial physician assessment and after one week of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53086
Reza Shaker, MD
4149556840
Mark Kern
4148053826

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