Study on the Safety, Tolerability and Efficacy of the Aqua Medical focal vapor ablation system, for the eradication of Barrett's Esophagus - part 2

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20279

Enrollment

Registered

2020-02-13

Start date

2021-06-28

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett esophagus, Barrett neoplasia

Interventions

Vapor ablation

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Flat Barrett's esophagus (BE) with an indication for ablation therapy ( either flat confirmed LGD, flat HGD, or residual flat BE after endoscopic resection of early, non-flat BE neoplasia)

Exclusion criteria

Exclusion criteria: Presence of visible lesions, history of advanced BE neoplasia (either sm2+, LVI+ or G3+).

Design outcomes

Primary

Measure	Time frame
BE surface regression after 8-12 weeks FU, incidence of adverse events	—

Secondary

Measure	Time frame
Feasibility to ablate the entire area as intended, duration of ablation, device malfunction, pain scores	—

Contacts

Public ContactSanne van Munster

Amsterdam UMC

s.n.vanmunster@amsterdamumc.nl0204447008

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)