RecruitingNot Applicable

Minimally Invasive Endoscopic Treatment of Zenker's Diverticulum Comparing LigaSureTM vs SB-Knife.

Spain80 participantsStarted 2021-06-28

Plain-language summary

The main purpose of this trial is to evaluate two devices used in the treatment of Zenker Diverticulum using flexible endoscopy (LigaSure and SB-knife). Analyze the technical success, clinical success, relapses, complications, and the mean procedure time with each device prospectively in order to transfer objective and uniform results to routine clinical practice.

Who can participate

Age range18 Years – 110 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with endoscopically confirmed Zenker's diverticulum and presenting symptoms related to it. * Those who complete the symptom and quality of life questionnaires. * They must sign informed consent. Exclusion Criteria: * Previous treatment of Zenker's Diverticulum * Those for whom Zenker's diverticulum is ruled out at endoscopy. * Chewing disorders and/or dysphagia secondary to neurological pathology and Oesophageal motility disorders * Those who do not want to participate in the study and/or who do not sign the informed consent.

What they're measuring

Evaluate the technical success of endoscopic diverticulotomy with SB-Knife and LigaSure

Timeframe: At the moment of the procedure

Evaluate clinical success of endoscopic diverticulotomy with SB-Knife and LigaSure

Timeframe: One month after the procedure

Trial details

NCT IDNCT04660214

SponsorHospital del Rio Hortega

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

Contact for this trial

Mª Henar Nuñez-Rodriguez, MD PhD

0034 983420 400 henarnrod@yahoo.es

View on ClinicalTrials.gov More Zenker Diverticulum trials