No registrations found.
ID
Source
Brief title
Health condition
Barrett's esophagus
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety will be assessed by the incidence and severity of any complications that are associated with the vapor ablation throughout the follow-up period.
The primary efficacy endpoint is the complete regression of intestinal metaplasia with each vapor ablation dose at 6-8 weeks follow-up as ascertained by endoscopic visualization and histopathologic evaluation.
Secondary outcome
Feasibility, tolerability, dose-effects
Study objective
This study will test the hypothesis that vapor ablation of Barrett esophagus is feasible and safe, and will result in regression of intestinal metaplasia to squamous epithelium.
Study design
Baseline endoscopy, follow-up endoscopy after 6-8 weeks to assess the primary endpoints.
Intervention
Single treatment session with Aqua Medical Focal Vapor Ablation System
Per patient, four ablations with varying doses will be applied in the Barrett's epithelium.
J.J.G.H.M. Bergman
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
0031 (0)205663556
j.j.bergman@amc.uva.nl
J.J.G.H.M. Bergman
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
0031 (0)205663556
j.j.bergman@amc.uva.nl
Inclusion criteria
Inclusion:
a. Subject is between 22 ¨C 85 years of age.
b. Subject should have Barrett esophagus, with either:
I. Barrett esophagus, circumferential extent ≥ 2 cm or tongues ≥ 3 cm, with an indication for ablation therapy, either:
i. Flat low grade dysplasia (LGD)
ii. Flat high grade dysplasia (HGD)
iii. Residual Barrett after removal of visible lesions, containing any grade of dysplasia, or early adenocarcinoma amendable for endoscopic treatment (mucosal or superficial submucosal disease, with well to moderately differentiation and without lymphovascular invasion).
II. Barrett esophagus containing a visible lesion with a type 0-IIa, 0-IIb or 0-IIc component, that requires endoscopic resection
c. Hiatal Hernia < 10cm
d. Subject has signed the informed consent form and is able to adhere to study visit schedule.
Exclusion criteria
Exclusion:
a. Subject has any condition that in the opinion of the PI preclude enrollment into the trial.
b. Subject has had a prior RF or cryoablation procedure
c. Subject has predictors for poor regression after ablation therapy, i.e. one of the following:
• In case of prior ER: regeneration of the ER scar with Barrett¡'s mucosa, OR
• Active reflux esophagitis grade C or D
• Esophageal narrowing pre-treatment with an estimated diameter <20mm
• Absence of squamous islands in the BE
d. Subject has any significant multisystem diseases.
e. Subject has a body mass index (BMI) greater than 40 kg/m2.
f. Subject has a hiatal hernia > 10cm
g. Subject has known moderate/severe gastroparesis
h. Subject is currently enrolled in other potentially confounding research.
i. Subject has an esophageal stenosis preventing the passage of an endoscope
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7270 |
| NTR-old | NTR7468 |
| CCMO | NL67326.018.18 |
| OMON | NL-OMON49629 |