What this study is
Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up.
What's being tested
- open, transcervical versus rigid endoscopic treatment
Intervention · PROCEDURE
The goal of the project is to perform the first prospective, multi-institutional long-term (5 year) study comparing the outcomes of open, transcervical versus rigid endoscopic treatment of cervical esophageal diverticulum and cricopharyngeal dysfunction in resolving associated symptoms, complications, and recurrence rates of dysphagia surgery. This study will also include cricopharyngeal bar as it pertains to an early Zenker's diverticulum.
Study details
- Official title
- A Complete Title Used for Approval Letters. Cervical Diverticulum Prospective, Multi-Institutional Study Proposal
- Sponsor
- University of Cincinnati
- Conditions
- Zenker Diverticulum · Progressive Dysphagia · Pharyngoesophageal Diverticulum
- Enrolling
- 500 people
- Starts
- 2017-08-15
- Est. completion
- 2027-06
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients with a diagnosis of cervical esophageal diverticulum, with Zenker's as most common, or CP bar (with diagnosis of early Zenker) as indicated on an esophagram who the participating institutions enroll regardless of surgical management and future treatments. Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up.
You can't join if
- Patients who undergo division of the common wall between the diverticulum and esophagus using flexible endoscopy will not be included in the study.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUC Health Otolaryngology-Head and Neck Surgery
Cincinnati, Ohio, United States
- Becky Reinert, CRC · Contact513-558-1719gibsonrk@uc.edu
- Rebecca Howell, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Cincinnati
Study ID 2016-6955
Principal investigator
Rebecca J Howell, MD
University of Cincinnati
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.