A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus

NARecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

March 25, 2022

Primary Completion Date

March 31, 2026

Study Completion Date

May 31, 2027

Conditions
Barrett EsophagusDysplasia
Interventions
DEVICE

Endorotor

"The treatment itself is preceded by a sub-mucosa saline and adrenalin solution injection administered by an endoscopic sclerotherapy needle lifting the submucosa and thus reducing the risk of perforation and hemorrhage.~The interventional tool is then applied tangentially to be brought into contact with the lifted mucosa, visual monitored by endoscope. The aspiration and sectioning system is activated by use of a pedal and a generator specially made for the system, used in every procedure. The entire surface area of the targeted mucosa must be covered by the probe. The residual tissue is then removed via the aspiration system and caught by a filter. The specimens are then easily retrievable at the end of the procedure and can be stored in formalin fixing solution for histological analysis."

DEVICE

Radiofrequency

"Endoscopic treatment using the HALO® 360 or 90 system is a thermal method for destroying the superficial mucosa. An initial debridement of the mucosal deposits is carried out by application of acetylcysteine in spray form with a spray catheter on the entire mucosal surface to be treated and then rinsed with water after a minute of application time.~For circumferential BEs, a single-use 360 Express® probe is used to make it possible to size the diameter of the esophagus and the treatment used. The length of the treatment area is 5 cm and several points of impact can be achieved by overlapping the catheter at two consecutive heights, with the zone spanned measuring one centimeter, in order to cover the entire pathological area requiring treatment.~For non-circumferential lesions a palette applicator is used in a variety of sizes, and in this context no sizing of the esophagus is required."

Trial Locations (12)

Unknown

NOT_YET_RECRUITING

University Hospital of Brest, Brest

NOT_YET_RECRUITING

University Hospital of Tours, Chambray-lès-Tours

NOT_YET_RECRUITING

University Hospital of Lille, Lille

NOT_YET_RECRUITING

University Hospital of Limoges, Limoges

RECRUITING

Edouard Herriot Hospital, Lyon

NOT_YET_RECRUITING

University Hospital of Nantes, Nantes

NOT_YET_RECRUITING

University Hospital of Nice, Nice

RECRUITING

Cochin Hospital, Paris

RECRUITING

Georges Pompidou European Hospital, Paris

RECRUITING

University Hospital of Bordeaux, Pessac

NOT_YET_RECRUITING

University Hospital of Poitiers, Poitiers

NOT_YET_RECRUITING

University Hospital of Rennes, Rennes

All Listed Sponsors
lead

University Hospital, Angers

OTHER_GOV