Clinical trial NCT04394468: The Use of plasmaJet During Operative Laparoscopy for Endometriosis
Official title: The Use of plasmaJet During Operative Laparoscopy for Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: feasibility of the PlasmaJet instrument
timeFrame: During laparoscopic surgery
measure: effectiveness of the PlasmaJet instrument
timeFrame: During laparoscopic surgery
measure: effectiveness of the PlasmaJet instrument
timeFrame: During laparoscopic surgery
measure: effectiveness of the PlasmaJet instrument
timeFrame: During laparoscopic surgery
measure: safety of the PlasmaJet instrument
timeFrame: During laparoscopic surgery until six weeks after surgery
measure: safety of the PlasmaJet instrument
timeFrame: During laparoscopic surgery until six weeks after surgery
measure: safety of the PlasmaJet instrument
timeFrame: During laparoscopic surgery until six weeks after surgery
measure: safety of the PlasmaJet instrument
timeFrame: During laparoscopic surgery until six weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University hospital Ghent
state: East-Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Tjalina Hamerlynck
role: PRINCIPAL_INVESTIGATOR
References: