ClinicalTrials.gg
CompletedNCT03429881Updated Feb 12, 2018

Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma.

An interventional study of Stripping versus laser CO2 in Microparticle, Endometriosis and Laparoscopy, sponsored by Francisco Carmona. Completed at 1 site in Spain. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-02-12.

Sponsored by Francisco Carmona · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 42 studies in Endometriosis with a site in Spain — 13 open to participants now, 15 under way, none of them phase 3. Endometriosis · Spain.

Enrollment
27th of 33
33 · median 90
Started
2018
with 3 others
No phase
18 of 42
8 open now
Registered
14th of 42
by date

Among the 42 studies in Endometriosis with a site in Spain, this one is the 27th largest by enrollment of the 33 interventional ones, is one of 4 that started in 2018, is one of 18 with no phase, and was the 14th registered.

By phase

42 studies; the count open now beside each. This study's row is marked.

No phasethis study18 · 8 open
Observational8 · 5 open
Phase 27 · 0 open
Phase 37 · 0 open
Phase 42 · 0 open

By the year they started

First in 2000; this study’s year is marked. 4 started in 2018.

Size and results

Median enrollment 90 across the 33 interventional studies, 70 across the 8 observational. Of the 22 that completed or were terminated, 6 (27%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 42 studies in Endometriosis with a site in Spain, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Microparticle
  • Endometriosis
  • Laparoscopy

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04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age between 18 and 40 years and unilateral symptomatic OEs ≥3 cm.

Exclusion criteria

Exclusion Criteria:

  • previous pelvic surgery, history of cancer, suspected , presurgical suspicion or evidence of deep endometriosis, presurgical suspicion or evidence of premature ovarian failure, and the use of estrogen suppressive drugs, including oral , 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Active comparator
    Laparoscopic stripping ovarian endometriomas

    Procedure: Stripping versus laser CO2

  • Active comparator
    Laser CO2 treatment ovarian endometriomas

    Procedure: Stripping versus laser CO2

Interventions

  • ProcedureStripping versus laser CO2

    Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.

06

What researchers measure

Primary outcomes

  1. Microparticle levels after two laparoscopic treatments of ovarian endometriomas

    Time frame: 1 month

07

Study locations

1 site
  • Hospital Clinic
    Barcelona, 08036, Spain
08

References and documents

Individual participant data

Plan to share: Yes — Publication in an indexed journal

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Within 2018

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Feb 2018, 0 months.

Of 196 non-industry interventional studies with no phase under Endometriosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 44. This study's 0 months is below that.

Counting every sponsor, half of 211 studies reached it within 25 months; a quarter within 13 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2018
First posted
Feb 12, 2018
StartActual
Feb 5, 2018
Primary completionActual
Feb 5, 2018
CompletionActual
Feb 5, 2018
Last update
Feb 12, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03429881
Lead sponsor
Francisco Carmona
Responsible party
Francisco Carmona (Professor, Hospital Clinic of Barcelona) — Sponsor-investigator
First posted
Feb 12, 2018
Start date
Feb 5, 2018
Primary completion
Feb 5, 2018
Completion
Feb 5, 2018
Last update
Feb 12, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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