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Clinical Trials in Italy / NCT03948438
Recruiting Observational

Endoscopic Treatment for Zenker's Diverticulum

NCT03948438 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Clinico Humanitas
Phase
Observational
Started
2009-01-01
Last updated
2022-09-21

Condition(s) studied

Zenker Diverticulum

Investigational drug(s) / intervention(s)

Endoscopic septotomy

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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * patients with symptomatic ZD treated by endoscopic procedures Exclusion Criteria: * pregnancy and breastfeeding

Primary outcome measure(s)

  • Incidence of Adverse Events — 24 hours after the procedure
    Any complications as bleeding, perforation, others

Trial sites (1)

FacilityCityRegionStatus
Humanitas Research Hospital Rozzano Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03948438 on ClinicalTrials.gov ↗ ← All trials in Italy