NCT02558504: HARMONI

Radiofrequency in the Treatment of Barrett's Oesophagus

Completed Phase 4 Last updated 2 October 2025

What this trial tests

Phase 4 trial testing Oesophagectomy in Esophageal Neoplasm in 87 participants. Completed in 18 January 2021.

Timeline

7 January 2013

Primary endpoint
18 January 2021

18 January 2021

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	87
Start date	7 January 2013
Primary completion	18 January 2021
Estimated completion	18 January 2021
Sites	1 location across France

Drugs / interventions tested

• Oesophagectomy
• Radiofrequency ablation

Conditions studied

• Esophageal Neoplasm — all drugs for Esophageal Neoplasm →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Esophageal Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

First intent treatment for superficial circular esophageal neoplasm is surgical resection. Endoscopic mucosal resection is not recommended due to the high rate of subsequent esophageal stenosis (higher than 80%).

Surgical limits are related to a high level of morbidity due, in particular, to respiratory complications or infections that require prolonged hospitalisations, and by significant rate of mortality (from 2 to 5 %). As an alternative to the surgical treatment, an innovative technique to remove esophageal circular preneoplastic and neoplastic lesions has been developed: it consists to ablate the mucosa by means of a balloon of a fixed diameter which incorporates approximately 100 electrodes on its surface that emit radiofrequency waves (HALO® Radiofrequency Ablation Technology System). By varying the strength and the duration of the electrical impulses, it is possible to obtain a homogenous and controlled destruction of the tissue of the whole mucosa, leaving no remaining pre-neoplastic or neoplastic elements underneath. The technique will be used for high grade glandular epithelial neoplasia, Vienna 4-1 or 4-2, developed on a mucosa at risk, i.e. the Barrett's oesophagus, occupying more than half of the circumference of the esophagus and that requires surgical treatment. The expected benefit for the patient is linked to the reduced invasiveness of the technique in comparison to the surgery

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.