EndometriosisENDOMETNCT06108167
Percutaneous Imaging-guided Cryoblation of the Anterior Abdominal Wall Endometriosis Scars
An observational study of Endometriosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Endometriosis is a common condition affecting 10% of women. It is characterized by the presence of ectopic endometrial cells. This pathology most frequently develops in the ovaries, utero-sacral ligaments and pelvic peritoneum, but also in the recto-sigmoid. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2023to 5 Nov 2023
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult woman (≥18 years old) Having benefited from cryotherapy of an abdominal wall endometriosis nodule between January 6, 2020 and January 2, 2023.
Who may be able to join
- Adult woman (≥18 years old) Having benefited from cryotherapy of an abdominal wall endometriosis nodule between January 6, 2020 and January 2, 2023.
- Subject not objecting to the reuse of their data for the purposes of this research
Who cannot join
- Subject having expressed its opposition to the reuse of its data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Gynécologie Obstétrique - CHU de Strasbourg - France
Strasbourg, 67091
Victor GABRIELE, MD, 33 3 69 55 34 04, victor.gabriele@chru-strasbourg.fr
Charlotte JOUFFRIEAU, MD, 33 3 69 55 34 04, Charlotte.jouff@gmail.com
About this study
Endometriosis is a common condition affecting 10% of women. It is characterized by the presence of ectopic endometrial cells. This pathology most frequently develops in the ovaries, utero-sacral ligaments and pelvic peritoneum, but also in the recto-sigmoid. Rarely, these lesions are found outside the pelvis, and even more exceptionally in the abdominal wall (in 0.03 to 1% of cases).
Cryotherapy has already been used for many years to treat soft tissue tumors (kidney and prostate tumors). It has also been successfully used by interventional radiologists to treat parietal desmoid tumors. After discussions with radiologists, given the similarity of location and extension of wall endometriosis lesions with desmoid tumours, the successes observed, and the scarcity of studies in the literature, it seemed appropriate to the investigators to study this new therapy.
The aim of this study was to investigate the efficacy of cryotherapy on parietal endometriosis lesions.
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Endometrial cells, Radiofrequency, Anterior abdominal, Cryotherapy
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of cryotherapy on parietal endometriosis lesions was assessed using the a visual analogue scale (VAS) ranging from 0 to 10.
Measured: Before and 6 months after the cryotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start5 May 2023
- Primary completion5 Nov 2023 (estimated)
- Study completion5 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108167
- Sponsor's protocol ID
- 8955
- Acronym
- ENDOMET
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Imaging-guided Cryoblation of the Anterior Abdominal Wall Endometriosis Scars
- ClinicalTrials.gov ID
- NCT06108167
- Acronym / sponsor ID
- ENDOMET / 8955
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Endometrial cells, Radiofrequency, Anterior abdominal, Cryotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 5 Nov 2023 (estimated)
- Study completion
- 5 Nov 2023 (estimated)
- First posted
- 30 Oct 2023 (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.
Endometriosis is a common condition affecting 10% of women. It is characterized by the presence of ectopic endometrial cells. This pathology most frequently develops in the ovaries, utero-sacral ligaments and pelvic peritoneum, but also in the recto-sigmoid. Rarely, these lesions are found outside the pelvis, and even more exceptionally in the abdominal wall (in 0.03 to 1% of cases).
Cryotherapy has already been used for many years to treat soft tissue tumors (kidney and prostate tumors). It has also been successfully used by interventional radiologists to treat parietal desmoid tumors. After discussions with radiologists, given the similarity of location and extension of wall endometriosis lesions with desmoid tumours, the successes observed, and the scarcity of studies in the literature, it seemed appropriate to the investigators to study this new therapy.
The aim of this study was to investigate the efficacy of cryotherapy on parietal endometriosis lesions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult woman (≥18 years old) Having benefited from cryotherapy of an abdominal wall endometriosis nodule between January 6, 2020 and January 2, 2023.
Key inclusion criteria (2 listed)
- Adult woman (≥18 years old) Having benefited from cryotherapy of an abdominal wall endometriosis nodule between January 6, 2020 and January 2, 2023.
- Subject not objecting to the reuse of their data for the purposes of this research
Key exclusion criteria (1 listed)
- Subject having expressed its opposition to the reuse of its data for scientific research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of cryotherapy on parietal endometriosis lesions was assessed using the a visual analogue scale (VAS) ranging from 0 to 10.
Time frame: Before and 6 months after the cryotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University Hospital, Strasbourg, France at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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 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.
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 Victor GABRIELE, MD (33 3 69 55 34 04, victor.gabriele@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of cryotherapy on parietal endometriosis lesions was assessed using the a visual analogue scale (VAS) ranging from 0 to 10. (time frame: Before and 6 months after the cryotherapy). 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 2 Nov 2023.