MicroparticleNCT03429881
Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma.
A study testing Stripping versus laser CO2 in people with Microparticle and Endometriosis, run by Francisco Carmona at 1 site in Spain.
Trial summary
Study objective: To evaluate serial generation of microparticles (MPs) after laparoscopic stripping or CO2 laser vaporization in surgical treatment of patients with ovarian endometrioma (OE). Design: A prospective, randomized, blinded, pilot study, including 33 patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Microparticle, Endometriosis, Laparoscopy
- What is being tested?
- Stripping versus laser CO2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 5 Feb 2018to 5 Feb 2018
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 40 years and unilateral symptomatic OEs ≥3 cm.
Who cannot join
- previous pelvic surgery, history of cancer, suspected malignancy, presurgical suspicion or evidence of deep endometriosis, presurgical suspicion or evidence of premature ovarian failure, and the use of estrogen suppressive drugs, including oral contraceptives, GnRH-agonists, progestins, or danazol in the preceding 3 months. We excluded patients with suspicion of deep endometriosis according to an extensive preoperative work-up (including magnetic resonance imaging when necessary) routinely performed in such patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma: a Pilot, Prospective, Randomized Study Comparing Stripping With CO2 Laser Vaporization
Study objective: To evaluate serial generation of microparticles (MPs) after laparoscopic stripping or CO2 laser vaporization in surgical treatment of patients with ovarian endometrioma (OE).
Design: A prospective, randomized, blinded, pilot study, including 33 patients. Setting: Tertiary university hospital from April 2015 to June 2017. Patients: 33 women with unilateral OE undergoing laparoscopic surgery. Intervention: Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.
Measurements and Main results: Blood samples were collected before surgery, and at 2 hours, 24 hours, 1 month, and 3 months after surgery. MPs generation curve after ovarian endometrioma surgery was performed.
- Conditions
- Microparticle, Endometriosis, Laparoscopy
- Being tested
- Stripping versus laser CO2
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stripping versus laser CO2Procedure or surgery
Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic stripping ovarian endometriomas | Active comparator | Not described Receives: Procedure: Stripping versus laser CO2 |
| Laser CO2 treatment ovarian endometriomas | Active comparator | Not described Receives: Procedure: Stripping versus laser CO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microparticle levels after two laparoscopic treatments of ovarian endometriomas
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start5 Feb 2018
- Primary completion5 Feb 2018
- Study completion5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicroparticleStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Carmona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Carmona, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429881
- Sponsor's protocol ID
- HCB/2015/0068
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication in an indexed journal
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma: a Pilot, Prospective, Randomized Study Comparing Stripping With CO2 Laser Vaporization
- ClinicalTrials.gov ID
- NCT03429881
- Acronym / sponsor ID
- HCB/2015/0068
- Conditions
- Microparticle, Endometriosis, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Francisco CarmonaUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 12 Feb 2018 (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.
Study objective: To evaluate serial generation of microparticles (MPs) after laparoscopic stripping or CO2 laser vaporization in surgical treatment of patients with ovarian endometrioma (OE).
Design: A prospective, randomized, blinded, pilot study, including 33 patients. Setting: Tertiary university hospital from April 2015 to June 2017. Patients: 33 women with unilateral OE undergoing laparoscopic surgery. Intervention: Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.
Measurements and Main results: Blood samples were collected before surgery, and at 2 hours, 24 hours, 1 month, and 3 months after surgery. MPs generation curve after ovarian endometrioma surgery was performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic stripping ovarian endometriomas | Active comparator | Procedure: Stripping versus laser CO2 |
| Laser CO2 treatment ovarian endometriomas | Active comparator | Procedure: Stripping versus laser CO2 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age between 18 and 40 years and unilateral symptomatic OEs ≥3 cm.
Key exclusion criteria (1 listed)
- previous pelvic surgery, history of cancer, suspected malignancy, presurgical suspicion or evidence of deep endometriosis, presurgical suspicion or evidence of premature ovarian failure, and the use of estrogen suppressive drugs, including oral contraceptives, GnRH-agonists, progestins, or danazol in the preceding 3 months. We excluded patients with suspicion of deep endometriosis according to an extensive preoperative work-up (including magnetic resonance imaging when necessary) routinely performed in such patients.
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 |
|---|---|---|
| Stripping versus laser CO2Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE. | Procedure or surgery | Laparoscopic stripping ovarian endometriomas, Laser CO2 treatment ovarian endometriomas |
Primary outcome
Microparticle levels after two laparoscopic treatments of ovarian endometriomas
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Individual participant dataSharing planned: Yes. Publication in an indexed journal
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stripping versus laser CO2 in people with Microparticle and Endometriosis, run by Francisco Carmona at 1 site in Spain.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Feb 2018. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microparticle levels after two laparoscopic treatments of ovarian endometriomas (time frame: 1 month). 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 12 Feb 2018.