Status:

NOT_YET_RECRUITING

Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)

Lead Sponsor:

Société Française d'Endoscopie Digestive

Conditions:

Zenker Diverticulum

Eligibility:

All Genders

18-90 years

Brief Summary

Prospective comparative observational study in numerous reference centers in France, comparing Tunnelization (Z-POEM) versus Non-Tunnelization Techniques according to the usual practices. This is a pr...

Eligibility Criteria

Inclusion

  • Patients with symptomatic Zenker's diverticulum (Augsburg score ≥5 )
  • Diagnostic evaluation including esophagogastroduodenoscopy (EGD) and a barium swallow (TOGD) with measurement of the diverticulum's height.
  • Patient aged 18 years or older
  • Patient with ASA 1, ASA 2, ASA 3 status
  • No participation in another concurrent clinical study

Exclusion

  • Patient under 18 years old
  • Patient with ASA 4 or ASA 5 status
  • Pregnant woman
  • Patient with coagulation disorders preventing the performance a polypectomy: PT \< 50%, Platelets \< 50,000/mm³, ongoing effective anticoagulation, or current clopidogrel use.
  • Patient who has already undergone initial endoscopic or surgical treatment for Zenker's diverticulum

Key Trial Info

Start Date :

October 31 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 31 2028

Estimated Enrollment :

128 Patients enrolled

Trial Details

Trial ID

NCT06594718

Start Date

October 31 2024

End Date

October 31 2028

Last Update

September 19 2024

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