Cap-Assisted Endoscopic Septotomy of Zenker's Diverticulum: Early and Long-Term Outcomes.
Alessandro Repici, Annalisa Cappello, Marco Spadaccini...
https://pubmed.ncbi.nlm.nih.gov/34236338/Actively Recruiting
Led by Istituto Clinico Humanitas · Updated on 2022-09-21
400
Participants Needed
1
Research Sites
N/A
Total Duration
Zenkers diverticulum is a rare, non-cancerous condition involving an outpouching near the throat and esophagus junction. This research aims to evaluate the safety and symptom relief of minimally invasive endoscopic procedures used to treat this condition. The study is observational and focuses on patients treated with these endoscopic methods. Participants undergo an endoscopic septotomy procedure, where an incision is made between the diverticulum and the esophagus using a flexible endoscope. The procedure is performed with the patient lying on their side, under conscious or deep sedation. Different endoscopic techniques like flexible endoscopic septum division or per-oral endoscopic septotomy may be used. During the study, researchers will monitor participants for any adverse events within 24 hours after the procedure and will assess symptoms for up to five years. The study involves regular follow-ups to track safety and symptom changes over time. Participants will be observed to understand the outcomes of these endoscopic treatments for Zenkers diverticulum.
CONDITIONS
Endoscopic Treatment for Zenker's Diverticulum
A
Alessandro Repici, Prof.
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Istituto Clinico Humanitas
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo an endoscopic septotomy procedure to treat Zenker's Diverticulum.
1 procedure visit (in-person)
Duration - Up to 5 years
Participants are monitored for symptoms and adverse events following the procedure.
1 visit 24 hours after procedure, then follow-up visits over 5 years
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Alessandro Repici, Annalisa Cappello, Marco Spadaccini...
https://pubmed.ncbi.nlm.nih.gov/34236338/Istituto Clinico Humanitas
Lead Sponsor