Endoscopic Treatment for Zenker's Diverticulum

September 19, 2022 updated by: Istituto Clinico Humanitas

Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum

Zenker's diverticulum (ZD) is a rare benign condition, due to an acquired sac-like outpouching of the mucosa and submucosa layers originating from the pharyngoesophageal junction. Endoscopic techniques like flexible endoscopic septum division (FESD) or per-oral endoscopic septotomy (POES), represent a minimally invasive alternative to surgery or to rigid endoscopic procedure to treat ZD. The goal of the research will be to evaluate the safety of the procedures and to measure Zenker-symptom severity in all patients treated by endoscopic procedures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Rozzano, Italy, 20089
        • Recruiting
        • Humanitas Research Hospital
        • Contact:
        • Sub-Investigator:
          • Milena Di Leo, MD
        • Sub-Investigator:
          • Roberta Maselli, PhD
        • Sub-Investigator:
          • Piera A Galtieri, MD
        • Sub-Investigator:
          • Elena Finati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients affected by ZD and treated by endoscopic procedures.

Description

Inclusion Criteria:

  • patients with symptomatic ZD treated by endoscopic procedures

Exclusion Criteria:

  • pregnancy and breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: 24 hours after the procedure
Any complications as bleeding, perforation, others
24 hours after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptoms after the procedure
Time Frame: up to 5 years
The frequency of symptoms such as dysphagia, regurgitation, weight loss
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Anticipated)

December 30, 2028

Study Completion (Anticipated)

December 30, 2028

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 9, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICH Zenker

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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