NCT01880892

Brief Summary

The purpose of this study is to see if people with reflux with a Zenker's diverticulum have increased reflux into the throat following a cricopharyngeal myotomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2018

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

4.6 years

First QC Date

June 14, 2013

Last Update Submit

July 22, 2022

Conditions

Laryngopharyngeal RefluxZenker's Diverticulum

Outcome Measures

Primary Outcomes (1)

  • Presence of LPR measured by: number of pH drops >3 standard deviations from baseline and the pharyngeal composite pH score.

    3 months postoperatively

Secondary Outcomes (3)

  • Reflux symptom index (RSI) score

    3 months postoperatively

  • Mayo Dysphagia Questionnaire Score

    3 months postoperatively

  • Reflux finding score

    3 months postoperatively

Study Arms (1)

Post cricopharyngeal myotomy

EXPERIMENTAL

Subjects scheduled to undergo an endoscopic criocopharyngeal myotomy, which is the standard treatment for a Zenker's diverticulum, will have levels of laryngopharyngeal reflux measured after the procedure.

Procedure: Cricopharyngeal myotomyDiagnostic Test: PH probe Testing

Interventions

Cricopharyngeal myotomyPROCEDURE

Endoscopic laser cricopharyngeal myotomy is one of the standard treatments for Zenker's Diverticulum. It takes about 30 minutes and at our institution requires a one night of observation in the hospital.

Post cricopharyngeal myotomy
PH probe TestingDIAGNOSTIC_TEST

24 hour PH probe testing, which will measure acid reflux following cricopharyngeal myotomy.

Post cricopharyngeal myotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptoms of gastroesophageal reflux
  • presence of Zenker's diverticulum or cricopharyngeal hypertrophy
  • undergoing surgery for Zenker's diverticulum or cricopharyngeal hypertrophy with endoscopic laser cricopharyngeal myotomy
  • at least 18 years old

You may not qualify if:

  • pregnant women
  • children
  • prisoners
  • adults lacking capacity to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

Laryngopharyngeal RefluxZenker Diverticulum

Condition Hierarchy (Ancestors)

Gastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesLaryngeal DiseasesRespiratory Tract DiseasesDiverticulum, EsophagealDiverticulumDiverticular DiseasesGastroenteritisPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • David Lott, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 19, 2013

Study Start

June 1, 2013

Primary Completion

January 2, 2018

Study Completion

January 2, 2018

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations

US(1)