Ovarian Endometrioma Ablation Using Plasma Energy Versus Cystectomy

PHASE2UnknownINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

Conditions
Ovarian Endometrioma
Interventions
PROCEDURE

Ablation using the PlasmaJet system

Ablation of the inner surface of the cyst is then performed using the PlasmaJet system in coagulation mode set at 40, at a distance averaging 5 mm from the tip of the handpiece, and with an exposure time limited to 1 to 2 seconds on each site. Care is taken not to leave any untreated sites and to ablate the edges of the invagination site and the corresponding peritoneal implants on the adjacent broad ligament.

PROCEDURE

Cystectomy

"Surgical excision of an ovarian endometrioma by cystectomy involves three distinct areas, each requiring a different excision procedure. Area A from where cyst invagination originates, measures 1 cm² on average and is revealed by lysing adhesions between the ovary and the adjacent broad ligament, leading to the characteristic chocolate fluid evacuation. The excision by scissors of area A allows the surgeon to identify a cleavage plane close to the cyst wall, which can be followed without significant bleeding (area B). Should adhesions appear in the cleavage plane, they are coagulated and cut, so as not to strip the ovarian cortex. Close to the ovarian hilus, for complete cyst removal, adhesions require coagulation using bipolar current and section by scissors (area C)."

Trial Locations (2)

63033

RECRUITING

University Hospital, Clermont-Ferrand

76031

RECRUITING

University Hospital, Rouen

Sponsors
All Listed Sponsors
lead

Plasma Surgical Inc

INDUSTRY

NCT01596985 - Ovarian Endometrioma Ablation Using Plasma Energy Versus Cystectomy | Biotech Hunter | Biotech Hunter