Comparing two devices for treating Zenker's Diverticulum using endoscopy
Minimally Invasive Endoscopic Treatment of Zenker's Diverticulum Comparing LigaSureTM vs SB-Knife.
This study is testing which of two devices, LigaSure or SB-Knife, works better for treating Zenker's Diverticulum through a special procedure called endoscopic diverticulotomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Hospital del Rio Hortega Academic / other |
| Locations | 1 site (Valladolid) |
| Trial ID | NCT04660214 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of two devices, LigaSure and SB-Knife, in performing endoscopic diverticulotomy for patients with Zenker's Diverticulum. Patients will be randomly assigned to receive treatment with either device, and the study will assess technical success, clinical outcomes, complications, and procedure duration. Prophylactic antibiotics will be administered, and the procedure will be conducted under deep sedation. The aim is to provide objective data to improve routine clinical practices for this condition.
Who should consider this trial
Good fit: Ideal candidates are patients with endoscopically confirmed Zenker's Diverticulum who experience related symptoms.
Not a fit: Patients who have previously undergone treatment for Zenker's Diverticulum or have dysphagia due to neurological issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from Zenker's Diverticulum.
How similar studies have performed: While similar endoscopic techniques have been explored, this specific comparison of LigaSure and SB-Knife is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Valladolid
- Mª Henar Núñez Rodriguez, — Valladolid, Spain (Recruiting)
Study contacts
- Principal investigator: Mª Henar Núñez-Rodriguez, MD PhD — Gastroenterology Department, Hospital Rio Hortega
- Study coordinator: Mª Henar Nuñez-Rodriguez, MD PhD
- Email: henarnrod@yahoo.es
- Phone: 0034 983420 400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.