Study into the accuracy of a new non-invasive device (Endosure test, EndoSure, Inc) for the diagnosis of endometriosis (ADDEND study)
| ISRCTN | ISRCTN83220665 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83220665 |
| IRAS number | 346375 |
| Secondary identifying numbers | BSGE grant application ref 36 |
- Submission date
- 15/12/2024
- Registration date
- 17/12/2024
- Last edited
- 13/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
We are conducting a pilot study to test a new non-invasive device called the Endosure test, which aims to diagnose endometriosis without surgery. Endometriosis is a condition where tissue similar to the lining inside the uterus grows outside it, causing pain and other symptoms.
Who can participate?
We are looking for three groups of women to participate:
Women scheduled for laparoscopic surgery due to pelvic pain (suspected endometriosis).
Women scheduled for laparoscopic surgery for other non-cancerous conditions.
Healthy female volunteers with no pelvic pain.
Participants must be pre-menopausal, aged 18-50 years, have no previous surgical detection or treatment of endometriosis, and no known cancer. They must also be willing to follow certain pre-test requirements.
What does the study involve?
Participants will:
Attend an additional one-hour research clinic.
Confirm they have followed pre-test requirements.
Complete a pelvic pain questionnaire.
Undergo the Endosure test, which is performed by trained staff.
For those undergoing surgery, standardized images will be taken during the procedure. Eight weeks after surgery, they will return for another clinic visit to repeat the questionnaire and Endosure test.
What are the possible benefits and risks of participating?
There are no risks associated with participating in this study. The potential benefit is helping to validate a device that could diagnose endometriosis without the need for invasive surgery.
Where is the study run from?
Worcestershire Acute Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
February 2024 to August 2027
Who is funding the study?
British Society for Gynaecology Endoscopy
Who is the main contact?
Donna Ghosh, donna.ghosh@nhs.net
Contact information
Public, Scientific, Principal Investigator
Obstetrics & Gynaecology department, Worcester Royal Hospital, Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
| Phone | +44 7753171100 |
|---|---|
| donna.ghosh@nhs.net |
Study information
| Study design | Interventional pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | 46561 ADDEND_Participant Information Sheet_DRAFT_V1.0_26-Nov-2024.pdf |
| Scientific 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) |
| Study acronym | ADDEND |
| Study objectives | GIMA can be adopted as a non-invasive biomarker in NHS in UK with good diagnostic results. |
| Ethics approval(s) |
Approved 30/04/2025, London - City & East Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048171; cityandeast.rec@hra.nhs.uk), ref: 25/LO/0341 |
| Health condition(s) or problem(s) studied | Non Invasive diagnosis of endometriosis |
| Intervention | 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 laparoscopic surgery. Total Duration of Treatment and Follow-Up: 8 weeks post-surgery. Study Arm 2: Surgical Control Group Treatment Given: Participants will undergo the Endosure test before and 8 weeks after laparoscopic surgery for benign conditions (e.g., laparoscopic sterilisation, cystectomy, fertility procedures). Total Duration of Treatment and Follow-Up: 8 weeks post-surgery. Study Arm 3: Healthy Volunteers (Non-Surgical Control Group) Treatment Given: Participants will undergo the Endosure test at baseline and 8 weeks later. Total Duration of Treatment and Follow-Up: 8 weeks. Summary of Procedures: Pre-Test Requirements: All participants must omit opioid medication for 7 days and prokinetic or antispasmodic medication for 3 days before the test. They must also fast for 8 hours prior to the test. Endosure Test: Conducted by trained staff, involving a standardized EVG with a water load satiety test (WLST). Surgery (for Arms 1 and 2): Standardized laparoscopic procedures with captured operative images for later review. Follow-Up: 8 weeks post-surgery or post-initial test, participants will repeat the Endosure test and complete a pain questionnaire. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Endosure |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/02/2024 |
| Completion date | 01/08/2027 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient, Health professional, Employee, All |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target number of participants | 90 |
| Key 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 |
| Key exclusion criteria | 1. Ages < 18 and > 50 years 2. Known malignant disease 3. Confirmed menopause 4. BMI > 35 kg/m² |
| Date of first enrolment | 01/08/2025 |
| Date of final enrolment | 01/08/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Sponsor information
Charity
BSGE Secretariat Royal College of Obstetricians & Gynaecologists
10-18 Union Street
London
SE11SZ
England
United Kingdom
| Phone | +44 2077726474 |
|---|---|
| bsge@rcog.org.uk |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/08/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Once completed the study will be published in a peer reviewed journal. |
| IPD sharing plan | The data will be owned by The Worcestershire Endometriosis Research Group, who will analyse the data and prepare the final report. The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request: donna.ghosh@nhs.net |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 26/11/2024 | 17/12/2024 | No | Yes |
| Protocol file | version 1.0 | 15/12/2024 | 17/12/2024 | No | No |
Additional files
Editorial Notes
13/08/2025: The ethics approval was added.
17/12/2024: Trial's existence confirmed by British Society For Gynaecological Endoscopy.
