Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy

Sponsor
Erbe Elektromedizin GmbH
Study ID
NCT07065214
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • APC — DEVICE
    For the surgical procedure for ovarian endometrioma treatment APCapplicator will be used
  • Lap bipolar forceps — DEVICE
    For ovarian endometrioma treatment the standard of care treatment will be performed.

Study Details

The study is a prospective, monocentric, randomized controlled, two-armed, pilot-study conducted at Department for Women's Health, Tuebingen, Germany. In this Post Market Study it will be determined whether and to what extent the two surgical procedures for ovarian endometrioma treatment (standard cystectomy versus APC) may affect the ovarian reserve by comparing changes in serum AMH levels after treatment. Seventy-two (72) patients who meet all eligibility criteria will undergo surgical procedure. The patients will be randomized into the group with standard cystectomy treatment or with APC treatment. Per group n=36 patients will be treated i.e., 1:1 randomization. A pre-specified primary endpoint analysis is planned after the last patient has undergo Visit 4 (Follow-up after 6 months) to analyze the primary endpoint. Screening takes place during the first visit (V1). During the second visit (V2) the participants will receive the ovarian endometriosis treatment procedure either with the APC or the standard cystectomy. Standard procedure (standard cystectomy) will be performed for additional endometriosis lesions. The follow up visits (V3 - V5) will take place after three, six and twelve months. Visit 3 and Visit 4 will take place at the study site and AMH will be measured. Whereas Visit 5 will take place via telemedical contact, i.e. phone call.

Key Dates

First listed
Jul 15, 2025
Start date
Nov 26, 2025
Status verified
Nov 2025
Primary completion
Mar 1, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Standard cystectomy
    Investigator uses lap bipolar forceps for endometrioma treatment (standard treatment)
  • Experimental: APC treatment
    Investigator uses APC applicator for endometrioma treatment. This is a CE approved device

Primary Outcome Measure

Concentration of AMH (Anti-Müller hormone) level [ Time Frame: Screening Visit 1 (up to -28 days before day 0); Visit 3 (day 0 +3 months +/- 14 days; Visit 4 (day 0 + 6 months +/- 14 days) ]

Central Contacts

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