The Use of plasmaJet During Operative Laparoscopy for Endometriosis (PLASMA)

Ghent University Hospital (UZ)

Status: Completed

Conditions: Endometriosis

Treatments: Device: PlasmaJet

Study type: Interventional

Funder types: Other

Identifiers

NCT04394468

EC/2019/1742

Details and patient eligibility

About

Endometriosis is a condition where functional endometrial tissue is present outside the uterus. It usually locates in the pelvis, which often includes the ovaries. One of the main concerns when performing surgery is to maintain fertility.

Nevertheless, a disadvantage of using monopolar and bipolar instruments for laparoscopic excision or coagulation of endometriosis lesions is the energy / thermal distribution that can cause damage to the surrounding healthy tissue. Therefore, the use of ultrasound, laser or plasma energy can potentially reduce damage to surrounding tissues and prevent adhesion formation. In addition, ablation of the internal surface of endometriomas can be an effective alternative to cystectomy.

The PlasmaJet system uses argon plasma which is released as kinetic, light and / or thermal energy. In this way the instrument can be applied within three functions, namely cutting, vaporizing and coagulating. Moreover, plasma will dissipate very quickly upon contact with tissue which consequently allows a controlled depth of tissue penetration. Thirdly, pure plasma energy differs from conventional electrosurgery since no electrical current will be spread through the tissue and therefore the thermal effect at surrounding tissues remains minimal.

The aim of this pilot study is to investigate the feasibility, effectiveness and safety of plasma energy in the treatment of endometriosis.

Enrollment: 23 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women between 18 and 45 years old.
• The presence of endometriosis; requiring surgical laparoscopy.

Exclusion criteria

• Women younger than 18 years.
• Women older than 45 years.
• Women who are scheduled for surgical laparoscopy where the removal of the uterus and / or ovaries is needed.
• Women who do not give written permission to participate.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

patient group

Other group

Description:

Data is collected from women (18-45y) with endometriosis (superficial and / or deep infiltrating endometriosis) where the preferred treatment is a laparoscopic intervention at UZ Gent.

Treatment:

Device: PlasmaJet