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Endoscopic Treatment for Zenker's Diverticulum

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ClinicalTrials.gov Identifier: NCT03948438
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Tracking Information
First Submitted Date May 8, 2019
First Posted Date May 14, 2019
Last Update Posted Date August 28, 2020
Actual Study Start Date January 1, 2009
Estimated Primary Completion Date December 30, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2019)
Incidence of Adverse Events [ Time Frame: 24 hours after the procedure ]
Any complications as bleeding, perforation, others
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 9, 2019)
symptoms after the procedure [ Time Frame: up to 5 years ]
The frequency of symptoms such as dysphagia, regurgitation, weight loss
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endoscopic Treatment for Zenker's Diverticulum
Official Title Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients affected by ZD and treated by endoscopic procedures.
Condition Zenker Diverticulum
Intervention Procedure: Endoscopic septotomy
Patients will be placed in left lateral decubitus position, either in conscious sedation or under deep sedation with propofol or endotracheal intubation.The procedure will be performed with a flexible standard endoscope and started with initial endoscopic examination with suction of possible retained material insidethe diverticulum. An incision of the bridge between the ZD and the esophagus will be done (using one endoscopic procedure as POES or FESD or other)
Study Groups/Cohorts Not Provided
Publications * Repici A, Cappello A, Spadaccini M, Nicoletti R, Carrara S, Fugazza A, Galtieri PA, Lamonaca L, Romana C, Badalamenti M, Di Leo M, Pellegatta G, Ferrara EC, Anderloni A, Maselli R. Cap-Assisted Endoscopic Septotomy of Zenker's Diverticulum: Early and Long-Term Outcomes. Am J Gastroenterol. 2021 Sep 1;116(9):1853-1858. doi: 10.14309/ajg.0000000000001356.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 9, 2019)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2028
Estimated Primary Completion Date December 30, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with symptomatic ZD treated by endoscopic procedures

Exclusion Criteria:

  • pregnancy and breastfeeding
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Alessandro Repici, Prof. alessandro.repici@hunimed.eu
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03948438
Other Study ID Numbers ICH Zenker
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Istituto Clinico Humanitas
Study Sponsor Istituto Clinico Humanitas
Collaborators Not Provided
Investigators Not Provided
PRS Account Istituto Clinico Humanitas
Verification Date August 2020