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

Primary Purpose

Endometriosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
PlasmaJet
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • University hospital Ghent

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patient group

Arm 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.

Outcomes

Primary Outcome Measures

feasibility of the PlasmaJet instrument
The surgeon's satisfaction with the use of plasma energy (5-point Likert scale).
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).
effectiveness of the PlasmaJet instrument
- completeness of resection or ablation, with a detailed description of deleted / ablated lesions.
effectiveness of the PlasmaJet instrument
- EFI score (Clinical instrument to predict pregnancy rates without IVF (ART) in patients after endometriosis surgery).
safety of the PlasmaJet instrument
- Need for conversion to laparotomy.
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.
safety of the PlasmaJet instrument
- Duration (in hours) of hospital stay after the procedure.
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.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2020
Last Updated
March 21, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04394468
Brief Title
The Use of plasmaJet During Operative Laparoscopy for Endometriosis
Acronym
PLASMA
Official Title
The Use of plasmaJet During Operative Laparoscopy for Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 7, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient group
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
PlasmaJet
Intervention Description
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.
Primary Outcome Measure Information:
Title
feasibility of the PlasmaJet instrument
Description
The surgeon's satisfaction with the use of plasma energy (5-point Likert scale).
Time Frame
During laparoscopic surgery
Title
effectiveness of the PlasmaJet instrument
Description
- 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).
Time Frame
During laparoscopic surgery
Title
effectiveness of the PlasmaJet instrument
Description
- completeness of resection or ablation, with a detailed description of deleted / ablated lesions.
Time Frame
During laparoscopic surgery
Title
effectiveness of the PlasmaJet instrument
Description
- EFI score (Clinical instrument to predict pregnancy rates without IVF (ART) in patients after endometriosis surgery).
Time Frame
During laparoscopic surgery
Title
safety of the PlasmaJet instrument
Description
- Need for conversion to laparotomy.
Time Frame
During laparoscopic surgery until six weeks after surgery
Title
safety of the PlasmaJet instrument
Description
- 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.
Time Frame
During laparoscopic surgery until six weeks after surgery
Title
safety of the PlasmaJet instrument
Description
- Duration (in hours) of hospital stay after the procedure.
Time Frame
During laparoscopic surgery until six weeks after surgery
Title
safety of the PlasmaJet instrument
Description
- 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.
Time Frame
During laparoscopic surgery until six weeks after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tjalina Hamerlynck
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Ghent
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

The Use of plasmaJet During Operative Laparoscopy for Endometriosis

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