Skip to content

Case-Control Study on PelviSound A.i.: Laparoscopic Intraabdominal Ultrasound-Guided Laser-Guided Core Needle Biopsy of the Uterus for Diagnosing Adenomyosis Uteri

Case-Control Study on PelviSound A.i.: Laparoscopic Intraabdominal Ultrasound-Guided Laser-Guided Core Needle Biopsy of the Uterus for Diagnosing Adenomyosis Uteri - MT_PelviSound Ai

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00034504
Enrollment
200
Registered
2025-01-14
Start date
2024-05-08
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis uteri

Interventions

Group 1: Patients who, with the preoperative clinical and/or imaging (sonographic) suspicion of endometriosis or an already targeted suspicion of adenomyosis uteri, undergo laparoscopy with the plan t

Sponsors

Department für Frauengesundheit am Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: - All patients who, due to a preoperative clinical and/or imaging (sonographic) suspicion of endometriosis or a targeted suspicion of adenomyosis uteri, undergo laparoscopy and for whom uterine preservation is planned as a clinical routine. - Control arm: All patients who undergo hysterectomy due to a benign condition and are younger than 60 years old.

Exclusion criteria

Exclusion criteria: - Expected lack of patient compliance or inability of the patient to understand the meaning and purpose of the clinical trial - Lack of patient consent

Design outcomes

Primary

MeasureTime frame
The study aim is to analyze whether a conspicuous sonographic finding corresponds to histologically confirmed adenomyosis. This will be evaluated using laparoscopic intra-abdominal sonography-guided and laser-assisted biopsy of the uterus.

Secondary

MeasureTime frame
1. Evaluation/validation of preoperative clinical and imaging (transvaginal sonographic) diagnosis of adenomyosis uteri with histology. 2. Evaluation/validation of intraoperative clinical and imaging (intra-abdominal sonographic) diagnosis of adenomyosis uteri with histology. 3. Retrospective assessment of the reliability of preoperative and intraoperative diagnosis of adenomyosis uteri in patients undergoing hysterectomy.

Countries

Germany

Contacts

Public ContactSascha Hoffmann

Department für Frauengesundheit am Universitätsklinikum Tübingen

sascha.hoffmann@med.uni-tuebingen.de+497071 29 82211

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026