A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With truFreeze™ Spray Cryotherapy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 13-001769
NCT ID: NCT01845454
Sponsor Protocol Number: 12-2603
About this study
The primary objective of this study is to determine the percentage segment regression after spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's Esophagus (BE) using truFreeze spray cryotherapy within the currently recommended therapeutic range. Secondary objectives are the determination of safety related outcomes such as esophageal stricture.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
This study has been terminated
Inclusion Criteria:
- English speaking males or females aged 18 to 85 who are candidates for sedated endoscopy with treatment of BE.
- At least 3 centimeters segment length of Barrett's Esophagus (BE) with or without circumferential involvement (i.e. CxM3) and with high grade or low grade dysplasia based on pathology results from 4 quadrant biopsies taken every 1-2 centimeter throughout the BE. All readings of dysplasia will be confirmed by an expert pathologist.
- Willing to undergo spray cryotherapy and judged by patient's physician as an appropriate candidate for this therapy.
- Able to read, comprehend, and complete the informed consent form
Exclusion Criteria:
- Bleeding disorder or other contraindication of spray cryotherapy.
- History of partial or complete esophagectomy.
- Current or past diagnosis of invasive esophageal cancer (previous intramucosal cancer is allowable, if removed by endoscopic mucosal resection with histologically confirmed negative lateral and deep margins).
- Pregnant women
- Contraindication to endoscopic spray cryotherapy as outlined in the directions for use for the device
- Previous endoscopic ablation treatment (such as radiofrequency ablation (RFA) or photodynamic therapy (PDT)).
- Previous chest external beam radiation therapy.
- Previous wide-area endoscopic resection or submucosal dissection. Previous focal mucosal resection is permitted (maximum 2 previous EMR's of 2cm or less removed representing less than 25% of the circumference of the esophagus removed).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Herbert Wolfsen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available