Endometriosis (Diagnosis)LUSNCT07427849
Observational Study on the Use of Ultrasound to Recognize Superficial Endometriosis in a Specific Area of the Pelvis (the Uterosacral Ligaments)
An observational study of Endometriosis (Diagnosis), run by Casa di Cura Dott. Pederzoli at 4 sites in Italy.
Trial summary
An observational, prospective, multicenter study conducted on patients of childbearing age undergoing laparoscopic surgery for early-stage benign or malignant gynecological disease. The study does not include changes to the standard care pathway. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis (Diagnosis)
- What is being tested?
- laparoscopic surgery for gynecological pathology
- How many people
- 64 participants
- Where
- 4 sitesItaly
- Study dates
- 17 Feb 2026to Aug 2026
- Phase
- Observational
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: the study is conducted in patients of childbearing age undergoing laparoscopic surgery for benign or malignant gynecological pathology in early stage. The study does not include changes to the standard care pathway. The indication for surgical treatment is given following the most up-to-date guidelines on the subject. Patients who are younger, postmenopausal, or have undergone previous pelvic surgery are excluded as these factors could alter the anatomy and ultrasound evaluation of LUS (uterosacral ligament).
Who may be able to join
- patients who need to undergo gynecological surgery with a laparoscopic approach for benign pathology (endometriosis, uterine fibroids, adenomyosis, chronic pelvic pain, benign ovarian cysts) or non-advanced malignant pathology (stage I endometrium and cervix, stage I and II ovary).
- patients who performed a level II gynecological ultrasound with an experienced operator in the preoperative pathway.
- technical possibility of performing a transvaginal ultrasound and the patient's willingness to undergo such an investigation.
- patients of childbearing age (18 - 50 years).
- Signing of informed consent.
Who cannot join
- presence of endometriosis deeply infiltrating the posterior compartment. This may interfere with the interpretation of uterosacral ligament (LUS) thickness as a specific marker of superficial endometriosis
- technical impossibility of performing a transvaginal ultrasound (patient virgo, patient refusal).
- incomplete ultrasound evaluation of the uterosacral ligaments for anatomical reasons or for the presence of endometriosis nodules from other sites with partial involvement of the LUS (uterosacral ligament).
- advanced malignant disease (>Stage I for endometrium and cervix, > Stage II for ovary)
- pelvic organ prolapse
- PID or other pelvic inflammatory diseases
Show all 9Show fewer
- medical emergencies (ovarian torsion, hemoperitoneum)
- postmenopausal patients
- previous pelvic surgery
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Not yet recruiting
Policlinico Abano Terme
Abano Terme, Padova, 35031
Manuel Maria Ianieri, MD, +39 049 8221211, direzionesanitaria@pec.policlinicoabano.it
- Not yet recruiting
Policlinico Universitario Federico II
Naples, Napoli, 80131
Pierluigi Giampaolino, MD
- Recruiting
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, 37019
Daniele Mautone, MD, +39 0456444193, urc@ospedalepederzoli.it
- Not yet recruiting
Presidio ospedaliero-universitario Santa Maria della Misericordia - Azienda Sanitaria Universitaria Friuli Centrale
Udine, Udine, 33100
Giuseppe Vizielli, MD
About this study
Official title: Ultrasound Diagnosis of Superficial Endometriosis of LUS (Uterosacral Ligaments): Definition of a Laparoscopically Validated Ultrasound Cut-off.
An observational, prospective, multicenter study conducted on patients of childbearing age undergoing laparoscopic surgery for early-stage benign or malignant gynecological disease. The study does not include changes to the standard care pathway.
Read the detailed description
All patients enrolled in the study will undergo a level II gynecological ultrasound with a transvaginal approach.
The uterosacral ligaments will be identified ultrasound-wise at the level of the cervix in a transverse scan, in line with the scanning techniques described in the literature. The first measurement point will be located in the median area, at the level of the torus uterinus; the further two measurements will be taken at the level of the LUS (uterosacral ligaments) 1.5 cm to the right and 1.5 cm to the left with respect to the torus. For each patient, the three measurements will be recorded and the average of the values obtained will be calculated, considered as a parameter representative of the average thickness of the LUS (uterosacral ligaments). The acquired ultrasound images will be archived as per clinical practice.
Subsequently, patients will undergo laparoscopic surgery. During the procedure, the presence or absence of superficial endometriosis lesions of the LUS will be documented, as well as the presence of any other locations of deep and superficial disease, according to a predefined grid.
Finally, ultrasound and laparoscopic data will be compared to assess diagnostic concordance at the site of primary interest (LUS), with particular reference to ultrasound thickness as a possible indicator of the presence of laparoscopically confirmed superficial endometriosis.
- Conditions
- Endometriosis (Diagnosis)
- Being tested
- laparoscopic surgery for gynecological pathology
- Keywords
- ultrasound, gynecology, laparoscopic surgery, uterosacral ligaments
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgery for gynecological pathologyOther
Patients will be operated on by operators experienced in complex endometriotic surgery.
Ultrasound and laparoscopic data will be compared regarding the site of interest for the study, the LUS.
LUS thickness data will be recorded as a continuous variable in mm. The uterosacral ligaments (LUS) will be identified at the level of the cervix in a transverse scan, rotated by 45 °, according to the method described in the literature. At this site, LUS present as hyperechoic striae located posterior to the cervix. The first measurement will be performed at the level of the uterine torus, in the median position. This will be the reference point for subsequent measurements. Two further measurements will be taken, one on each side: one point will be located on the LUS 1.5 cm to the right and another 1.5 cm to the left of the torus uterinum. For each patient, the three measurements will be recorded and the average of the three measurements will be calculated as an additional parameter
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of of the thickness of the LUS (uterosacral ligaments)
Three points (central, right and left) of measurement and calculation of the average between measurements. A ROC analysis (Receiver Operating Characteristic) will then be conducted to identify an optimal thickness cutoff value that can predict the presence of superficial endometriosis
Measured: through study completion, an average of 1 year
diagnostic performance parameters
Sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve (AUC), will be calculated by comparing ultrasound data with laparoscopic findings.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start17 Feb 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis (Diagnosis)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Dott. Pederzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427849
- Sponsor's protocol ID
- 818CET
- Acronym
- LUS
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Diagnosis of Superficial Endometriosis of LUS (Uterosacral Ligaments): Definition of a Laparoscopically Validated Ultrasound Cut-off.
- ClinicalTrials.gov ID
- NCT07427849
- Acronym / sponsor ID
- LUS / 818CET
- Conditions
- Endometriosis (Diagnosis)
- Keywords
- ultrasound, gynecology, laparoscopic surgery, uterosacral ligaments
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Casa di Cura Dott. PederzoliUniversity, hospital or other
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 23 Feb 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.
An observational, prospective, multicenter study conducted on patients of childbearing age undergoing laparoscopic surgery for early-stage benign or malignant gynecological disease. The study does not include changes to the standard care pathway.
Detailed description
All patients enrolled in the study will undergo a level II gynecological ultrasound with a transvaginal approach.
The uterosacral ligaments will be identified ultrasound-wise at the level of the cervix in a transverse scan, in line with the scanning techniques described in the literature. The first measurement point will be located in the median area, at the level of the torus uterinus; the further two measurements will be taken at the level of the LUS (uterosacral ligaments) 1.5 cm to the right and 1.5 cm to the left with respect to the torus. For each patient, the three measurements will be recorded and the average of the values obtained will be calculated, considered as a parameter representative of the average thickness of the LUS (uterosacral ligaments). The acquired ultrasound images will be archived as per clinical practice.
Subsequently, patients will undergo laparoscopic surgery. During the procedure, the presence or absence of superficial endometriosis lesions of the LUS will be documented, as well as the presence of any other locations of deep and superficial disease, according to a predefined grid.
Finally, ultrasound and laparoscopic data will be compared to assess diagnostic concordance at the site of primary interest (LUS), with particular reference to ultrasound thickness as a possible indicator of the presence of laparoscopically confirmed superficial endometriosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- the study is conducted in patients of childbearing age undergoing laparoscopic surgery for benign or malignant gynecological pathology in early stage. The study does not include changes to the standard care pathway. The indication for surgical treatment is given following the most up-to-date guidelines on the subject. Patients who are younger, postmenopausal, or have undergone previous pelvic surgery are excluded as these factors could alter the anatomy and ultrasound evaluation of LUS (uterosacral ligament).
Key inclusion criteria (5 listed)
- patients who need to undergo gynecological surgery with a laparoscopic approach for benign pathology (endometriosis, uterine fibroids, adenomyosis, chronic pelvic pain, benign ovarian cysts) or non-advanced malignant pathology (stage I endometrium and cervix, stage I and II ovary).
- patients who performed a level II gynecological ultrasound with an experienced operator in the preoperative pathway.
- technical possibility of performing a transvaginal ultrasound and the patient's willingness to undergo such an investigation.
- patients of childbearing age (18 - 50 years).
- Signing of informed consent.
Key exclusion criteria (9 listed)
- presence of endometriosis deeply infiltrating the posterior compartment. This may interfere with the interpretation of uterosacral ligament (LUS) thickness as a specific marker of superficial endometriosis
- technical impossibility of performing a transvaginal ultrasound (patient virgo, patient refusal).
- incomplete ultrasound evaluation of the uterosacral ligaments for anatomical reasons or for the presence of endometriosis nodules from other sites with partial involvement of the LUS (uterosacral ligament).
- advanced malignant disease (>Stage I for endometrium and cervix, > Stage II for ovary)
- pelvic organ prolapse
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 |
|---|---|---|
| laparoscopic surgery for gynecological pathologyPatients will be operated on by operators experienced in complex endometriotic surgery. Ultrasound and laparoscopic data will be compared regarding the site of interest for the study, the LUS. LUS thickness data will be recorded as a continuous variable in mm. The uterosacral ligaments (LUS) will be identified at the level of the cervix in a transverse scan, rotated by 45 °, according to the method described in the literature. At this site, LUS present as hyperechoic striae located posterior to the cervix. The first measurement will be performed at the level of the uterine torus, in the median position. This will be the reference point for subsequent measurements. Two further measurements will be taken, one on each side: one point will be located on the LUS 1.5 cm to the right and another 1.5 cm to the left of the torus uterinum. For each patient, the three measurements will be recorded and the average of the three measurements will be calculated as an additional parameter | Other | – |
Primary outcome
measurement of of the thickness of the LUS (uterosacral ligaments)
Time frame: through study completion, an average of 1 year
Three points (central, right and left) of measurement and calculation of the average between measurements. A ROC analysis (Receiver Operating Characteristic) will then be conducted to identify an optimal thickness cutoff value that can predict the presence of superficial endometriosis
diagnostic performance parameters
Time frame: through study completion, an average of 1 year
Sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve (AUC), will be calculated by comparing ultrasound data with laparoscopic findings.
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 25 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Italy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis (Diagnosis), run by Casa di Cura Dott. Pederzoli at 4 sites in Italy.
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 9 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 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of of the thickness of the LUS (uterosacral ligaments) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 25 Feb 2026.