Ovarian EndometriomaPhase 2NCT01596985
Ovarian Endometrioma Ablation Using Plasma Energy Versus Cystectomy
A Phase 2 study testing Ablation using the PlasmaJet system and Cystectomy in people with Ovarian Endometrioma, run by Plasma Surgical Inc at 2 sites in France.
Trial summary
Objective: To compare loss of ovarian parenchyma following ovarian endometrioma ablation using the PlasmaJet system versus cystectomy, using postoperative examination by 3D ultrasound. Design: Prospective comparative study. Setting: Two experienced surgeons practicing in two University tertiary referral centers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovarian Endometrioma
- What is being tested?
- Ablation using the PlasmaJet system and Cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2010to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 45 years;
- Surgery required by pelvic pain or infertility related to endometriosis;
- Clinical and imaging data proving unilateral ovarian endometrioma which diameter exceeds 30 mm.
Who cannot join
- Previous surgery on ovaries or IVF procedures;
- Bilateral endometriomas;
- Pregnancy
- Woman not French speaker.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
University Hospital
Clermont-Ferrand, Auvergne, 63033
Michel Canis, MD PhD, +33473750750, mcanis@chu-clermontferrand.fr
Michel Canis, MD
- Recruiting
University Hospital
Rouen, Seine-Maritime, 76031
Horace Roman, MD PhD, +33232888643, horace.roman@gmail.com
Horace Roman, MD, PhD
About this study
Official title: Prospective, Monocentric Study Comparing Cystectomy to PlasmaJet Ablation in the Surgical Management of Ovarian Endometriomas
Objective: To compare loss of ovarian parenchyma following ovarian endometrioma ablation using the PlasmaJet system versus cystectomy, using postoperative examination by 3D ultrasound.
Design: Prospective comparative study. Setting: Two experienced surgeons practicing in two University tertiary referral centers.
Patients: Fifty women with no previous history of ovarian surgery managed for unilateral ovarian endometrioma > 30 mm in diameter.
Interventions: Endometrioma ablation by plasma energy using the PlasmaJet system and ovarian tissue sparing cystectomy.
Main Outcome Measures: 3D ultrasound assessment of postoperative reduction in ovarian volume and antral follicle count (AFC) .
Read the detailed description
The management of ovarian endometriomas in women wishing to conceive remains challenging. Recent data suggest that excising endometriomas by ovarian tissue sparing cystectomy does not avoid inadvertent removal of ovarian parenchyma surrounding the cyst, particularly in enlarged cysts. Although several authors question whether the ovarian parenchyma immediately surrounding the cyst may still be functional, there is little doubt that postoperative fertility could be significantly impaired by loss of ovarian cortex and provokes the question as to whether pregnancy should be initiated before performing a cystectomy, whenever this scenario is possible. However ovarian surgery cannot always be delayed to the postpartum period, numerous women require endometrioma management while not seeking an immediate pregnancy and still wish to conserve their procreative capabilities.
After a period of some years during which cystectomy appeared to be the best surgical technique in the treatment of ovarian endometriomas in women wishing to become pregnant, recent data have suggested that ablation of the inner layer of the endometrioma may be a valuable alternative technique, as long as the energy employed avoids thermal diffusion to surrounding ovarian tissue. The Department of Gynecology at the University Hospital in Rouen, France have introduced ablation by plasma energy using the PlasmaJet system (Plasma Surgical Ltd, Abingdon, UK) and have already been able to report encouraging results based on non comparative pilot studies and on retrospective "before and after" comparative study.
The aim of the study is to prospectively compare loss of ovarian parenchyma and decrease in antral follicle count (AFC) following ovarian endometrioma ablation using plasma energy versus cystectomy, when performed by only two expert surgeons. Postoperative examination is carried out by 3D ultrasound.
- Conditions
- Ovarian Endometrioma
- Being tested
- Ablation using the PlasmaJet system, Cystectomy
- Keywords
- Endometrioma, Endometriosis, Cystectomy, Ablation, Plasma energy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation using the PlasmaJet systemProcedure or surgery
Also called Ovarian cyst ablation, Ablation by plasma energy
Ablation of the inner surface of the cyst is then performed using the PlasmaJet system in coagulation mode set at 40, at a distance averaging 5 mm from the tip of the handpiece, and with an exposure time limited to 1 to 2 seconds on each site. Care is taken not to leave any untreated sites and to ablate the edges of the invagination site and the corresponding peritoneal implants on the adjacent broad ligament.
CystectomyProcedure or surgery
Also called Cyst excision, Ovarian stripping
Surgical excision of an ovarian endometrioma by cystectomy involves three distinct areas, each requiring a different excision procedure. Area A from where cyst invagination originates, measures 1 cm² on average and is revealed by lysing adhesions between the ovary and the adjacent broad ligament, leading to the characteristic "chocolate fluid" evacuation. The excision by scissors of area A allows the surgeon to identify a cleavage plane close to the cyst wall, which can be followed without significant bleeding (area B). Should adhesions appear in the cleavage plane, they are coagulated and cut, so as not to strip the ovarian cortex. Close to the ovarian hilus, for complete cyst removal, adhesions require coagulation using bipolar current and section by scissors (area C).
| Study group | Role | What they receive |
|---|---|---|
| Ablation using the PlasmaJet system | Experimental | Origin of cyst invagination is identified after lysis of adhesions between ovary and adjacent broad ligament, leading to characteristic "chocolate fluid" evacuation. Surgeon then attempts to turn cyst completely inside out via original invagination site of diameter averaging 1 to 2cm. Ablation of cyst's inner surface is performed using the PlasmaJet system in coagulation mode set at 40, at distance averaging 5mm from tip of handpiece, and with exposure time limited to 1 to 2s on each site. Care is taken not to leave any untreated sites and to ablate the edges of the invagination site and corresponding peritoneal implants on adjacent broad ligament. When cyst reversion is not feasible, surgeon progressively exposes cyst interior to guide plasma beam at an angle perpendicular to the inner surface. Receives: Procedure: Ablation using the PlasmaJet system |
| Cystectomy | Active comparator | Surgical excision of an ovarian endometrioma by cystectomy involves three distinct areas, each requiring a different excision procedure. Area A from where cyst invagination originates, measures 1 cm² on average and is revealed by lysing adhesions between the ovary and the adjacent broad ligament, leading to the characteristic "chocolate fluid" evacuation. The excision by scissors of area A allows the surgeon to identify a cleavage plane close to the cyst wall, which can be followed without significant bleeding (area B). Should adhesions appear in the cleavage plane, they are coagulated and cut, so as not to strip the ovarian cortex. Close to the ovarian hilus, for complete cyst removal, adhesions require coagulation using bipolar current and section by scissors (area C). Receives: Procedure: Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of ovarian volume
Evaluation of ovarian volumes of both the operated and the contralateral healthy ovary using a tridimensional ultrasound by vaginal route. The volume of each ovary expressed in cm³ was estimated using the formula D1 x D2 x D3 x π / 6. The Mann and Whitney test is performed to compare measurements made on the operated ovaries vs. those made on the contralateral ovaries.
Measured: 3 months postoperatively
Secondary outcomes (2)
Decrease in ovarian antral follicles count (AFC)
Evaluation of antral follicle counts in both the operated and the contralateral, healthy ovary, using tridimensional ultrasound. The Mann and Whitney test is performed to compare the decrease in AFC depending on surgical procedure.
Measured: 3 months postoperatively
Antimullerian Hormone level (AMH)
AMH level are measured before and 3 months after the surgery to evaluate the decrease in AMH level depending on surgical technique.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startNov 2010
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian EndometriomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plasma Surgical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Horace Roman, MD, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596985
- Sponsor's protocol ID
- P.S.PJ.6.10.GYN
- Status last verified
- May 2012
- First submitted
- 9 May 2012
- Last updated
- 14 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Roman H, Bubenheim M, Auber M, Marpeau L, Puscasiu L. Antimullerian hormone level and endometrioma ablation using plasma energy. JSLS. 2014 Jul-Sep;18(3):e2014.00002. doi: 10.4293/JSLS.2014.00002.
PubMed 25392649
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Monocentric Study Comparing Cystectomy to PlasmaJet Ablation in the Surgical Management of Ovarian Endometriomas
- ClinicalTrials.gov ID
- NCT01596985
- Acronym / sponsor ID
- P.S.PJ.6.10.GYN
- Conditions
- Ovarian Endometrioma
- Keywords
- Endometrioma, Endometriosis, Cystectomy, Ablation, Plasma energy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Plasma Surgical IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 11 May 2012 (estimated)
- 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.
Objective: To compare loss of ovarian parenchyma following ovarian endometrioma ablation using the PlasmaJet system versus cystectomy, using postoperative examination by 3D ultrasound.
Design: Prospective comparative study. Setting: Two experienced surgeons practicing in two University tertiary referral centers.
Patients: Fifty women with no previous history of ovarian surgery managed for unilateral ovarian endometrioma > 30 mm in diameter.
Interventions: Endometrioma ablation by plasma energy using the PlasmaJet system and ovarian tissue sparing cystectomy.
Main Outcome Measures: 3D ultrasound assessment of postoperative reduction in ovarian volume and antral follicle count (AFC) .
Detailed description
The management of ovarian endometriomas in women wishing to conceive remains challenging. Recent data suggest that excising endometriomas by ovarian tissue sparing cystectomy does not avoid inadvertent removal of ovarian parenchyma surrounding the cyst, particularly in enlarged cysts. Although several authors question whether the ovarian parenchyma immediately surrounding the cyst may still be functional, there is little doubt that postoperative fertility could be significantly impaired by loss of ovarian cortex and provokes the question as to whether pregnancy should be initiated before performing a cystectomy, whenever this scenario is possible. However ovarian surgery cannot always be delayed to the postpartum period, numerous women require endometrioma management while not seeking an immediate pregnancy and still wish to conserve their procreative capabilities.
After a period of some years during which cystectomy appeared to be the best surgical technique in the treatment of ovarian endometriomas in women wishing to become pregnant, recent data have suggested that ablation of the inner layer of the endometrioma may be a valuable alternative technique, as long as the energy employed avoids thermal diffusion to surrounding ovarian tissue. The Department of Gynecology at the University Hospital in Rouen, France have introduced ablation by plasma energy using the PlasmaJet system (Plasma Surgical Ltd, Abingdon, UK) and have already been able to report encouraging results based on non comparative pilot studies and on retrospective "before and after" comparative study.
The aim of the study is to prospectively compare loss of ovarian parenchyma and decrease in antral follicle count (AFC) following ovarian endometrioma ablation using plasma energy versus cystectomy, when performed by only two expert surgeons. Postoperative examination is carried out by 3D ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation using the PlasmaJet system | Experimental | Procedure: Ablation using the PlasmaJet systemOrigin of cyst invagination is identified after lysis of adhesions between ovary and adjacent broad ligament, leading to characteristic "chocolate fluid" evacuation. Surgeon then attempts to turn cyst completely inside out via original invagination site of diameter averaging 1 to 2cm. Ablation of cyst's inner surface is performed using the PlasmaJet system in coagulation mode set at 40, at distance averaging 5mm from tip of handpiece, and with exposure time limited to 1 to 2s on each site. Care is taken not to leave any untreated sites and to ablate the edges of the invagination site and corresponding peritoneal implants on adjacent broad ligament. When cyst reversion is not feasible, surgeon progressively exposes cyst interior to guide plasma beam at an angle perpendicular to the inner surface. |
| Cystectomy | Active comparator | Procedure: CystectomySurgical excision of an ovarian endometrioma by cystectomy involves three distinct areas, each requiring a different excision procedure. Area A from where cyst invagination originates, measures 1 cm² on average and is revealed by lysing adhesions between the ovary and the adjacent broad ligament, leading to the characteristic "chocolate fluid" evacuation. The excision by scissors of area A allows the surgeon to identify a cleavage plane close to the cyst wall, which can be followed without significant bleeding (area B). Should adhesions appear in the cleavage plane, they are coagulated and cut, so as not to strip the ovarian cortex. Close to the ovarian hilus, for complete cyst removal, adhesions require coagulation using bipolar current and section by scissors (area C). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 45 years;
- Surgery required by pelvic pain or infertility related to endometriosis;
- Clinical and imaging data proving unilateral ovarian endometrioma which diameter exceeds 30 mm.
Key exclusion criteria (4 listed)
- Previous surgery on ovaries or IVF procedures;
- Bilateral endometriomas;
- Pregnancy
- Woman not French speaker.
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 |
|---|---|---|
| Ablation using the PlasmaJet systemAlso: Ovarian cyst ablation, Ablation by plasma energyAblation of the inner surface of the cyst is then performed using the PlasmaJet system in coagulation mode set at 40, at a distance averaging 5 mm from the tip of the handpiece, and with an exposure time limited to 1 to 2 seconds on each site. Care is taken not to leave any untreated sites and to ablate the edges of the invagination site and the corresponding peritoneal implants on the adjacent broad ligament. | Procedure or surgery | Ablation using the PlasmaJet system |
| CystectomyAlso: Cyst excision, Ovarian strippingSurgical excision of an ovarian endometrioma by cystectomy involves three distinct areas, each requiring a different excision procedure. Area A from where cyst invagination originates, measures 1 cm² on average and is revealed by lysing adhesions between the ovary and the adjacent broad ligament, leading to the characteristic "chocolate fluid" evacuation. The excision by scissors of area A allows the surgeon to identify a cleavage plane close to the cyst wall, which can be followed without significant bleeding (area B). Should adhesions appear in the cleavage plane, they are coagulated and cut, so as not to strip the ovarian cortex. Close to the ovarian hilus, for complete cyst removal, adhesions require coagulation using bipolar current and section by scissors (area C). | Procedure or surgery | Cystectomy |
Primary outcome
Loss of ovarian volume
Time frame: 3 months postoperatively
Evaluation of ovarian volumes of both the operated and the contralateral healthy ovary using a tridimensional ultrasound by vaginal route. The volume of each ovary expressed in cm³ was estimated using the formula D1 x D2 x D3 x π / 6. The Mann and Whitney test is performed to compare measurements made on the operated ovaries vs. those made on the contralateral ovaries.
2 secondary outcomes
Decrease in ovarian antral follicles count (AFC)
Time frame: 3 months postoperatively
Antimullerian Hormone level (AMH)
Time frame: 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
- Derived from this study: PubMed 25392649Roman H, Bubenheim M, Auber M, Marpeau L, Puscasiu L. Antimullerian hormone level and endometrioma ablation using plasma energy. JSLS. 2014 Jul-Sep;18(3):e2014.00002. doi: 10.4293/JSLS.2014.00002.
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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. This study is not recruiting at the moment.
Horace Roman, MD, PhD principal investigator
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ablation using the PlasmaJet system and Cystectomy in people with Ovarian Endometrioma, run by Plasma Surgical Inc at 2 sites in France.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Horace Roman, MD PhD (0033232888643, Horace.Roman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of ovarian volume (time frame: 3 months postoperatively). 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 NCT01596985, which also lists 1 linked publication.
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 14 May 2012.