Endorotor Resection In Refractory Barrett's Dysplasia Patients
Stopped: POOR RECRUITMENT
United States, Sweden, United Kingdom15 participantsStarted 2018-02-09
Plain-language summary
The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.
Who can participate
Age range30 Years – 89 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
✓. Subjects who are greater than 30 and less than 90 years of age; inclusive of males and females.
✓. Subjects with confirmed Barrett's esophagus with dysplasia (low-grade or high-grade) and meeting at least one of the following criteria:
✓. Failed at least 1 ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-procedure dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.
✓. Residual Barrett's length is ≥1 cm and ≤6 cm.
✓. No confirmed evidence of esophageal adenocarcinoma (EAC) at the time of therapy.
✓. Subject capable of giving informed consent.
✓. Subject has a reasonable expectation for prolonged survival (greater than 2 years).
Exclusion criteria
✕
What they're measuring
1
Incidence of complete removal of refractory Barrett's esophagus
Timeframe: 12 months
2
Rate of device- and procedure-related serious adverse events (SAEs)