ADDEND Study
Research type
Research Study
Full title
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)
IRAS ID
346375
Contact name
Donna Ghosh
Contact email
Sponsor organisation
Worcestershire Acute Hospitals NHS Trust
ISRCTN Number
ISRCTN83220665
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
We propose to conduct a pilot study of the non-invasive diagnostic device for endometriosis, Endosure test (EndoSure, Inc).
We will recruit 3 patient groups of at least 78 subjects within the Trust: group 1 is patients listed for elective primary laparoscopic surgery due to pelvic pain (suspected endometriosis); group 2 is patients listed for elective laparoscopic surgery for other benign conditions (surgical control group); group 3 is healthy female volunteers (from trust staff) of with no pelvic pain (non-surgical control group). Inclusion criteria for all groups includes: pre-menopausal status; age 18-50 years; no previous surgical detection or treatment of endometriosis; no known malignancy; acceptability to patient of pre-test requirements (omission of opioid medication for 7 days prior to the test, omission of prokinetic or anti-spasmodic medication for 3 days prior to test, nil by mouth for 8 hours prior to the test). Surgical patients in group 1 and 2 are recruited from clinics and theatre waiting lists; healthy volunteers from group 3 are self-referral from hospital advertisements (weekly electronic staff newsletter and posters).
All participants will be contacted by the research team for information and consent.
All participants will: book into an additional one-hour research clinic; confirm adherence to the pre-test requirements; complete an EHP-30 pelvic pain questionnaire; undertake the Endosure test by trained staff. Results will be stored on a named-only-access computer directory, blinded to surgical team.
Surgery will be performed on patients in groups 1 and 2. Standardised and stipulated captured operative images from diagnostic laparoscopy will be saved onto the laparoscopic stack and retrieved onto a study hard drive. 8 weeks following surgery patients will attend a repeat visit to the research clinic with the same requirements of questionnaire and Endosure test. Review of captured operative images separately by two endometriosis surgeons will classify disease presence and severity. Unblinding of Endosure test results once all data has been collected will be compared with surgical confirmation or absence of disease. All results will be analysed and the study written up with the endometriosis team at Worcestershire Acute Hospitals NHS Trust approving the final manuscript for publication submission.REC name
London - City & East Research Ethics Committee
REC reference
25/LO/0341
Date of REC Opinion
30 Apr 2025
REC opinion
Further Information Favourable Opinion