First in-human study on the Safety, Tolerability and Efficacy of the Aqua Medical focal vapor ablation system, for the eradication of Barrett*s Esophagus

Phase 2

Completed

• Conditions: Esophageal Carcinoma; Intestinal Metaplasia; 10017990; 10017987

• Registration Number: NL-OMON49629
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

a. Subject is between 22 * 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 with a visible lesion with a type 0-IIa, -IIb or -IIc
component, requiring 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified