EndometriosisOVAPLASNCT07065214
Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy
A study testing APC and Lap bipolar forceps in people with Endometriosis, run by Erbe Elektromedizin GmbH at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- APC and Lap bipolar forceps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 26 Nov 2025to 30 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Indication for surgical endometrioma treatment according to patient symptoms
- Signed informed consent
Who cannot join
- Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial
- Prior procedures at the ovaries
- Recurrent endometrioma (patients with recurrent endometriosis outside of the ovar, e.g. peritoneal endometriosis lesions can be included)
- Pregnant or breastfeeding patients
- Participation in any other clinical study that could affect the AMH level or pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department for Women's Health
Tübingen, Germany, 72076
Bernhard Krämer, Prof. Dr. med., +49 7071 29 82211, bernhard.kraemer@med.uni-tuebingen.de
About this study
Official title: Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy: A Prospective Controlled Randomized Pilot Study
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.
Read more
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.
- Conditions
- Endometriosis
- Being tested
- APC, Lap bipolar forceps
- Keywords
- ovarian endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APCDevice
Also called APC Treatment with APCapplicator
For the surgical procedure for ovarian endometrioma treatment APCapplicator will be used
Lap bipolar forcepsDevice
For ovarian endometrioma treatment the standard of care treatment will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Standard cystectomy | Other | Investigator uses lap bipolar forceps for endometrioma treatment (standard treatment) Receives: Device: Lap bipolar forceps |
| APC treatment | Experimental | Investigator uses APC applicator for endometrioma treatment. This is a CE approved device Receives: Device: APC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of AMH (Anti-Müller hormone) level
The comparison of patient AMH changes (ΔAMH) before and after surgery (Follow up Visit after 3 and 6 months) with either APC or standard cystectomy (ΔAMH Group 1 versus ΔAMH Group 2).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start26 Nov 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erbe Elektromedizin GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernhard Krämer, Prof. Dr. med., Principal investigator, Department for Women's Health, Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065214
- Sponsor's protocol ID
- OVAPLAS
- Acronym
- OVAPLAS
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Younis JS, Shapso N, Ben-Sira Y, Nelson SM, Izhaki I. Endometrioma surgery-a systematic review and meta-analysis of the effect on antral follicle count and anti-Mullerian hormone. Am J Obstet Gynecol. 2022 Jan;226(1):33-51.e7. doi: 10.1016/j.ajog.2021.06.102. Epub 2021 Jul 13.
PubMed 34265271Stefanovic S, Sutterlin M, Gaiser T, Scharff C, Neumann M, Berger L, Froemmel N, Tuschy B, Berlit S. Microscopic, Macroscopic and Thermal Impact of Argon Plasma, Diode Laser, and Electrocoagulation on Ovarian Tissue. In Vivo. 2023 Mar-Apr;37(2):531-538. doi: 10.21873/invivo.13111.
PubMed 36881055Lockyer EK, Schreurs A, Lier M, Dekker J, Melgers I, Mijatovic V. Treatment of ovarian endometriomas using plasma energy in endometriosis surgery: effect on pelvic pain, return to work, pregnancy and cyst recurrence. Facts Views Vis Obgyn. 2019 Mar;11(1):49-55.
PubMed 31695857Working group of ESGE, ESHRE, and WES; Saridogan E, Becker CM, Feki A, Grimbizis GF, Hummelshoj L, Keckstein J, Nisolle M, Tanos V, Ulrich UA, Vermeulen N, De Wilde RL. Recommendations for the surgical treatment of endometriosis-part 1: ovarian endometrioma. Gynecol Surg. 2017;14(1):27. doi: 10.1186/s10397-017-1029-x. Epub 2017 Dec 19.
PubMed 29285022Muzii L, Achilli C, Bergamini V, Candiani M, Garavaglia E, Lazzeri L, Lecce F, Maiorana A, Maneschi F, Marana R, Perandini A, Porpora MG, Seracchioli R, Spagnolo E, Vignali M, Benedetti Panici P. Comparison between the stripping technique and the combined excisional/ablative technique for the treatment of bilateral ovarian endometriomas: a multicentre RCT. Hum Reprod. 2016 Feb;31(2):339-44. doi: 10.1093/humrep/dev313. Epub 2015 Dec 18.
PubMed 26682578
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy: A Prospective Controlled Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT07065214
- Acronym / sponsor ID
- OVAPLAS / OVAPLAS
- Conditions
- Endometriosis
- Keywords
- ovarian endometriosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Erbe Elektromedizin GmbHIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard cystectomy | Other | Device: Lap bipolar forcepsInvestigator uses lap bipolar forceps for endometrioma treatment (standard treatment) |
| APC treatment | Experimental | Device: APCInvestigator uses APC applicator for endometrioma treatment. This is a CE approved device |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Indication for surgical endometrioma treatment according to patient symptoms
- Signed informed consent
Key exclusion criteria (5 listed)
- Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial
- Prior procedures at the ovaries
- Recurrent endometrioma (patients with recurrent endometriosis outside of the ovar, e.g. peritoneal endometriosis lesions can be included)
- Pregnant or breastfeeding patients
- Participation in any other clinical study that could affect the AMH level or pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APCAlso: APC Treatment with APCapplicatorFor the surgical procedure for ovarian endometrioma treatment APCapplicator will be used | Device | APC treatment |
| Lap bipolar forcepsFor ovarian endometrioma treatment the standard of care treatment will be performed. | Device | Standard cystectomy |
Primary outcome
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)
The comparison of patient AMH changes (ΔAMH) before and after surgery (Follow up Visit after 3 and 6 months) with either APC or standard cystectomy (ΔAMH Group 1 versus ΔAMH Group 2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 34265271Younis JS, Shapso N, Ben-Sira Y, Nelson SM, Izhaki I. Endometrioma surgery-a systematic review and meta-analysis of the effect on antral follicle count and anti-Mullerian hormone. Am J Obstet Gynecol. 2022 Jan;226(1):33-51.e7. doi: 10.1016/j.ajog.2021.06.102. Epub 2021 Jul 13.
- Background: PubMed 36881055Stefanovic S, Sutterlin M, Gaiser T, Scharff C, Neumann M, Berger L, Froemmel N, Tuschy B, Berlit S. Microscopic, Macroscopic and Thermal Impact of Argon Plasma, Diode Laser, and Electrocoagulation on Ovarian Tissue. In Vivo. 2023 Mar-Apr;37(2):531-538. doi: 10.21873/invivo.13111.
- Background: PubMed 31695857Lockyer EK, Schreurs A, Lier M, Dekker J, Melgers I, Mijatovic V. Treatment of ovarian endometriomas using plasma energy in endometriosis surgery: effect on pelvic pain, return to work, pregnancy and cyst recurrence. Facts Views Vis Obgyn. 2019 Mar;11(1):49-55.
- Background: PubMed 29285022Working group of ESGE, ESHRE, and WES; Saridogan E, Becker CM, Feki A, Grimbizis GF, Hummelshoj L, Keckstein J, Nisolle M, Tanos V, Ulrich UA, Vermeulen N, De Wilde RL. Recommendations for the surgical treatment of endometriosis-part 1: ovarian endometrioma. Gynecol Surg. 2017;14(1):27. doi: 10.1186/s10397-017-1029-x. Epub 2017 Dec 19.
- Background: PubMed 26682578Muzii L, Achilli C, Bergamini V, Candiani M, Garavaglia E, Lazzeri L, Lecce F, Maiorana A, Maneschi F, Marana R, Perandini A, Porpora MG, Seracchioli R, Spagnolo E, Vignali M, Benedetti Panici P. Comparison between the stripping technique and the combined excisional/ablative technique for the treatment of bilateral ovarian endometriomas: a multicentre RCT. Hum Reprod. 2016 Feb;31(2):339-44. doi: 10.1093/humrep/dev313. Epub 2015 Dec 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernhard Krämer, Prof. Dr. med. principal investigator
Department for Women's Health, Tuebingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APC and Lap bipolar forceps in people with Endometriosis, run by Erbe Elektromedizin GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Steinmetz (+49 70717552850, vanessa.steinmetz@erbe-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07065214, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.