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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Device: PlasmaJet

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eline Meireson, Msc; Phone Number: 093327817; Email: eline.meireson@uzgent.be

Study Locations

• Belgium
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: patient group; 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.

Device: PlasmaJet; Data will be collected during two contact moments, in particular during her admission for surgical laparoscopy, and during her postoperative check-up. Both of these are standard of care. No additional questionnaires will be taken. During the admission the postoperative pain scoreswill be monitored and collected. The duration of her stay in the hospital will also be recorded. During the postoperative check-up, which takes usually place six weeks after the surgery, complications will registered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility of the PlasmaJet instrument	The surgeon's satisfaction with the use of plasma energy (5-point Likert scale).	During laparoscopic surgery
effectiveness of the PlasmaJet instrument	- Whether or not to use additional instruments to achieve hemostasis (monopolar or bipolar coagulation) and / or complete resection of the lesions (monopolar or ultrasonic energy).	During laparoscopic surgery
effectiveness of the PlasmaJet instrument	- completeness of resection or ablation, with a detailed description of deleted / ablated lesions.	During laparoscopic surgery
effectiveness of the PlasmaJet instrument	- EFI score (Clinical instrument to predict pregnancy rates without IVF (ART) in patients after endometriosis surgery).	During laparoscopic surgery
safety of the PlasmaJet instrument	- Need for conversion to laparotomy.	During laparoscopic surgery until six weeks after surgery
safety of the PlasmaJet instrument	- Serious complications up to 6 weeks after the operation. The most common complications that can occur with surgical laparoscopy are bleeding, damage to the surrounding tissues / structures and the formation of adhesions.	During laparoscopic surgery until six weeks after surgery
safety of the PlasmaJet instrument	- Duration (in hours) of hospital stay after the procedure.	During laparoscopic surgery until six weeks after surgery
safety of the PlasmaJet instrument	- Postoperative pain scores (VAS) (2 hours postoperatively, maximum pain scores during the days after surgery until the patient is discharged). Hereby the pain score is registered every hour during the stay in the PACU (Post-anesthesia care department). Afterwards, the pain score is recorded every four hours.	During laparoscopic surgery until six weeks after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Tjalina Hamerlynck, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: EC/2019/1742

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No