Study into the accuracy of a new non-invasive device (Endosure test, EndoSure, Inc) for the diagnosis of endometriosis (ADDEND study)

Pilot study to investigate the Accuracy and potential clinical application of a non-invasive Diagnostic Device, EVG Clinical Decision Tool (Endosure test, EndoSure Inc), in the diagnosis and management of ENDometriosis (ADDEND Study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN83220665

Enrollment

Registered

2024-12-17

Start date

2025-08-01

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Non Invasive diagnosis of endometriosis Urological and Genital Diseases

Interventions

Study Arms and Methodology: Study Arm 1: Suspected Endometriosis Patients Treatment Given: Participants will undergo the Endosure test (EVG Clinical Decision Tool) before and 8 weeks after laparoscop

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Ages 18 – 50 years 2. Acceptable to patient to omit: 2.1. opioid medication (eg. Codeine, Morphine, etc) 7 days before test 2.2. prokinetic or antispasmodic medication (eg. Erythromycin, Domperidone etc) 3 days before test

Exclusion criteria

Exclusion criteria: 1. Ages 50 years 2. Known malignant disease 3. Confirmed menopause 4. BMI > 35 kg/m²

Design outcomes

Primary

Measure	Time frame
1. Presence of endometriosis is measured using Endosure test at baseline and 8 weeks post-surgery 2. Severity of endometriosis is measured using Endosure test at baseline and 8 weeks post-surgery 3. Absence of endometriosis is measured using Endosure test at baseline and 8 weeks post-surgery	—

Secondary

Measure	Time frame
1. Pain levels are measured using EHP-30 questionnaire at baseline and 8 weeks post-surgery 2. Gastrointestinal myoelectrical activity is measured using Electroviscerogram with WLST at baseline and 8 weeks post-surgery 3. Surgical confirmation of endometriosis is measured using laparoscopic images at baseline 4. Diagnostic accuracy is measured using comparison of Endosure test results with surgical findings at baseline and 8 weeks post-surgery 5. Sensitivity and specificity of Endosure test are measured using statistical analysis of test results at baseline and 8 weeks post-surgery 6. Patient adherence to pre-test requirements is measured using patient self-report at baseline 7. Patient satisfaction with diagnostic process is measured using patient feedback questionnaire at 8 weeks post-surgery	—

Measure

Time frame

1. Pain levels are measured using EHP-30 questionnaire at baseline and 8 weeks post-surgery 2. Gastrointestinal myoelectrical activity is measured using Electroviscerogram with WLST at baseline and 8 weeks post-surgery 3. Surgical confirmation of endometriosis is measured using laparoscopic images at baseline 4. Diagnostic accuracy is measured using comparison of Endosure test results with surgical findings at baseline and 8 weeks post-surgery 5. Sensitivity and specificity of Endosure test are measured using statistical analysis of test results at baseline and 8 weeks post-surgery 6. Patient adherence to pre-test requirements is measured using patient self-report at baseline 7. Patient satisfaction with diagnostic process is measured using patient feedback questionnaire at 8 weeks post-surgery

—

Countries

England, United Kingdom

Contacts

Public ContactDonna Ghosh

donna.ghosh@nhs.net+44 7753171100

Outcome results

None listed

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