Ovarian EndometriomaENDO-ARGONNCT07711743
Histological Assessment of Tissue Penetration Depth of Argon Beam Coagulation in Ovarian Endometriomas
A study testing Argon Plasma Coagulation in people with Ovarian Endometrioma and Endometriosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to evaluate the depth of tissue penetration of Argon Beam Coagulation (ABC) during laparoscopic surgery for ovarian endometriomas. Researchers want to determine how deeply ABC affects ovarian tissue and to generate data on the safety of this surgical technique. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Endometrioma, Endometriosis
- What is being tested?
- Argon Plasma Coagulation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Jul 2026to 7 Aug 2027
- 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
- Female patients aged 18-40 years.
- Indication for surgical treatment of ovarian endometrioma based on clinical symptoms and/or imaging findings.
- Diagnosis of ovarian endometrioma ≥3 cm confirmed by preoperative imaging (ultrasound and/or MRI).
- Planned laparoscopic cystectomy.
- Written informed consent.
Who cannot join
- Expected lack of compliance or inability to understand the study procedures.
- Previous surgical procedures on the affected ovary.
- Recurrent ovarian endometrioma.
- Pregnancy or breastfeeding.
- Participation in another interventional clinical study that may influence study outcomes, such as anti-Müllerian hormone (AMH) levels 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.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Obstetrics and Gynecology, Inselspital Bern
Bern, Canton of Bern, 3008
Flavia Pagano, MD, +41 31 632 38 12, flavia.pagano@insel.ch
Sara Imboden, PD, +41 31 632 38 12, sara.imboden@insel.ch
About this study
Official title: Histological Assessment of Tissue Penetration Depth of Argon Beam Coagulation in Ovarian Endometriomas: A Prospective Pilot Study
The goal of this clinical trial is to evaluate the depth of tissue penetration of Argon Beam Coagulation (ABC) during laparoscopic surgery for ovarian endometriomas. Researchers want to determine how deeply ABC affects ovarian tissue and to generate data on the safety of this surgical technique.
Participants will undergo standard laparoscopic surgery for ovarian endometriomas. During the planned surgical procedure, Argon Beam Coagulation will be applied to the ovarian surface according to the study protocol. The treated tissue will subsequently be excised as part of the planned surgery and analyzed histologically to measure the depth of tissue penetration.
Read the detailed description
Endometriosis is a chronic inflammatory disease affecting approximately 10% of women of reproductive age. Ovarian endometriomas are a common manifestation of the disease and frequently require surgical treatment. Conventional cystectomy may unintentionally remove healthy ovarian tissue, potentially reducing ovarian reserve and affecting future fertility. Tissue-preserving surgical techniques are therefore of increasing clinical interest.
Argon Beam Coagulation (ABC) is an energy-based surgical technology that allows non-contact coagulation using ionized argon gas. Although ABC is increasingly used in endometriosis surgery, limited histological evidence is available regarding the depth of tissue penetration produced by this technique.
This prospective, single-center interventional study will enroll women undergoing laparoscopic surgery for ovarian endometriomas at the University Hospital Bern. During the planned surgical procedure, Argon Beam Coagulation will be applied to the ovarian surface according to a standardized protocol. The treated tissue will subsequently be excised during the same operation and processed for histological examination.
The primary objective of the study is to quantify the histological depth of tissue penetration of Argon Beam Coagulation in ovarian tissue. Secondary objectives include evaluating the consistency of tissue penetration and generating data that may support the safe use of ABC as a tissue-preserving surgical technique in the management of ovarian endometriomas.
- Conditions
- Ovarian Endometrioma, Endometriosis
- Being tested
- Argon Plasma Coagulation
- Keywords
- Argon Beam Coagulation, Ovarian Endometrioma, Endometriosis, Laparoscopy, Histopathology, Tissue Penetration, Ovarian Cystectomy, Fertility Preservation, Ovarian Reserve
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon Plasma CoagulationProcedure or surgery
Standardized argon plasma coagulation (APC) is applied to the outer surface of the ovarian endometrioma capsule immediately before laparoscopic cystectomy. The resected tissue is subsequently processed for histological analysis to assess the depth of APC tissue penetration.
| Study group | Role | What they receive |
|---|---|---|
| Argon Plasma Coagulation Before Ovarian Endometrioma Cystectomy | Experimental | Participants undergo standardized argon plasma coagulation (APC) on the surface of the ovarian endometrioma capsule immediately before laparoscopic cystectomy. The resected capsule is subsequently analyzed histologically to determine the depth of APC tissue penetration Receives: Procedure: Argon Plasma Coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of thermal tissue effects in the ovarian endometrioma cyst wall
Histological measurement of the maximum depth of tissue penetration induced by argon plasma coagulation in the ovarian endometrioma capsule after standardized pre-cystectomy application.
Measured: Immediately after surgery (Day 0)
Secondary outcomes (6)
Presence of residual endometriotic epithelium
Histological assessment of residual endometriotic epithelium after argon beam coagulation.
Measured: At surgery (Day 0)
Completeness of cyst lining ablation
Histological assessment of the completeness of ablation of the ovarian endometrioma cyst lining after argon beam coagulation.
Measured: Immediately after surgery (Day 0)
Thermal damage to adjacent ovarian parenchyma
Histological assessment of thermal damage extending into adjacent ovarian tissue.
Measured: At surgery (Day 0)
Technical success of argon beam application
Feasibility of standardized intraoperative argon beam coagulation, documented as successful completion of the planned procedure.
Measured: During surgery (Day 0)
Intraoperative complications
Occurrence of intraoperative complications related to the surgical procedure or study intervention.
Measured: During surgery (Day 0)
Postoperative complications
Occurrence of postoperative complications following surgery.
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start9 Jul 2026
- Primary completion7 Jul 2027 (estimated)
- Study completion7 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian EndometriomaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711743
- Sponsor's protocol ID
- ENDO-ARGON-01
- Other IDs
- Protocol ID
- Acronym
- ENDO-ARGON
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing plans have not yet been determined.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Assessment of Tissue Penetration Depth of Argon Beam Coagulation in Ovarian Endometriomas: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07711743
- Acronym / sponsor ID
- ENDO-ARGON / ENDO-ARGON-01
- Conditions
- Ovarian Endometrioma, Endometriosis
- Keywords
- Argon Beam Coagulation, Ovarian Endometrioma, Endometriosis, Laparoscopy, Histopathology, Tissue Penetration, Ovarian Cystectomy, Fertility Preservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 7 Jul 2027 (estimated)
- Study completion
- 7 Aug 2027 (estimated)
- First posted
- 17 Jul 2026 (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 goal of this clinical trial is to evaluate the depth of tissue penetration of Argon Beam Coagulation (ABC) during laparoscopic surgery for ovarian endometriomas. Researchers want to determine how deeply ABC affects ovarian tissue and to generate data on the safety of this surgical technique.
Participants will undergo standard laparoscopic surgery for ovarian endometriomas. During the planned surgical procedure, Argon Beam Coagulation will be applied to the ovarian surface according to the study protocol. The treated tissue will subsequently be excised as part of the planned surgery and analyzed histologically to measure the depth of tissue penetration.
Detailed description
Endometriosis is a chronic inflammatory disease affecting approximately 10% of women of reproductive age. Ovarian endometriomas are a common manifestation of the disease and frequently require surgical treatment. Conventional cystectomy may unintentionally remove healthy ovarian tissue, potentially reducing ovarian reserve and affecting future fertility. Tissue-preserving surgical techniques are therefore of increasing clinical interest.
Argon Beam Coagulation (ABC) is an energy-based surgical technology that allows non-contact coagulation using ionized argon gas. Although ABC is increasingly used in endometriosis surgery, limited histological evidence is available regarding the depth of tissue penetration produced by this technique.
This prospective, single-center interventional study will enroll women undergoing laparoscopic surgery for ovarian endometriomas at the University Hospital Bern. During the planned surgical procedure, Argon Beam Coagulation will be applied to the ovarian surface according to a standardized protocol. The treated tissue will subsequently be excised during the same operation and processed for histological examination.
The primary objective of the study is to quantify the histological depth of tissue penetration of Argon Beam Coagulation in ovarian tissue. Secondary objectives include evaluating the consistency of tissue penetration and generating data that may support the safe use of ABC as a tissue-preserving surgical technique in the management of ovarian endometriomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Argon Plasma Coagulation Before Ovarian Endometrioma Cystectomy | Experimental | Procedure: Argon Plasma CoagulationParticipants undergo standardized argon plasma coagulation (APC) on the surface of the ovarian endometrioma capsule immediately before laparoscopic cystectomy. The resected capsule is subsequently analyzed histologically to determine the depth of APC tissue penetration |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female patients aged 18-40 years.
- Indication for surgical treatment of ovarian endometrioma based on clinical symptoms and/or imaging findings.
- Diagnosis of ovarian endometrioma ≥3 cm confirmed by preoperative imaging (ultrasound and/or MRI).
- Planned laparoscopic cystectomy.
- Written informed consent.
Key exclusion criteria (5 listed)
- Expected lack of compliance or inability to understand the study procedures.
- Previous surgical procedures on the affected ovary.
- Recurrent ovarian endometrioma.
- Pregnancy or breastfeeding.
- Participation in another interventional clinical study that may influence study outcomes, such as anti-Müllerian hormone (AMH) levels 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 |
|---|---|---|
| Argon Plasma CoagulationStandardized argon plasma coagulation (APC) is applied to the outer surface of the ovarian endometrioma capsule immediately before laparoscopic cystectomy. The resected tissue is subsequently processed for histological analysis to assess the depth of APC tissue penetration. | Procedure or surgery | Argon Plasma Coagulation Before Ovarian Endometrioma Cystectomy |
Primary outcome
Depth of thermal tissue effects in the ovarian endometrioma cyst wall
Time frame: Immediately after surgery (Day 0)
Histological measurement of the maximum depth of tissue penetration induced by argon plasma coagulation in the ovarian endometrioma capsule after standardized pre-cystectomy application.
6 secondary outcomes
Presence of residual endometriotic epithelium
Time frame: At surgery (Day 0)
Completeness of cyst lining ablation
Time frame: Immediately after surgery (Day 0)
Thermal damage to adjacent ovarian parenchyma
Time frame: At surgery (Day 0)
Technical success of argon beam application
Time frame: During surgery (Day 0)
Intraoperative complications
Time frame: During surgery (Day 0)
Postoperative complications
Time frame: Up to 30 days after surgery
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 17 Jul 2026.
- Individual participant dataSharing planned: Undecided. Data sharing plans have not yet been determined.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argon Plasma Coagulation in people with Ovarian Endometrioma and Endometriosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 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 17 Jul 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 Switzerland. 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 Michael David Mueller, Prof. (+41 31 63 2 12 01, Michel.Mueller@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depth of thermal tissue effects in the ovarian endometrioma cyst wall (time frame: Immediately after surgery (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.