EndometriosisNCT05245695
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
An observational study of Endometriosis, run by Aspira Women's Health at 10 sites in United States.
Trial summary
The goal of this observational study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - "EndoCheck" - as an "aid in diagnosis" for endometriosis and to show validity as a diagnostic test Read more about this study
- Who is it for?
- Ages 14 to 50 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 1,200 participants
- Where
- 10 sitesUnited States
- Study dates
- 12 Jul 2022to 30 Nov 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 14 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women scheduled for a gynecologic surgery
Who may be able to join
- Participant is willing and able to provide written informed consent.
- Participant is a female aged 14 to 50 years old at time of consent.
- Participant is scheduled to undergo laparotomy or laparoscopy for symptomology consistent with possible endometriosis
Who cannot join
- Participant is a female in a pre-menarchal state.
- Participant is pregnant.
- Participant has an active malignancy.
- Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
- Participant has an active pelvic infection or other infections contraindicated for surgery.
- Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug/ device/ procedure was or is planned to be administered.
- Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.
- Participant is under 14 years old or over 50 years old
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Silvana Franco contact
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
Samya El Sayed, MD, selsaye4@jh.edu
James Segar, Dr
- Recruiting
Velvet Clinical Research
Burbank, California, 91506
Monica Torres, 3235270907, mtorres@velvetclinicalresearch.com
Jose Medrano, MD
- Recruiting
New Horizons Clinical Trials
Chandler, Arizona, 852224
Saira Flores, MD, sflores@aoafamily.com
(480) 496-2236
- Recruiting
Seven Hills Clinical Research
Cincinnati, Ohio, 45242
Brigette Tillman, brigette.tillman@axiawh.com
Gerard Reilly
- Recruiting
Midtown OBGYN North
Columbus, Georgia, 31909
Rebecca Watkins, rebeccaw@midtownob.com
Serena Tidwell
- Recruiting
Cindy Basinski, MD
Forest Hill, Indiana, 47630
Alicia Sollman, 812-853-3500, alicia@drbasinski.com
Cindy Basinski, MD
- Recruiting
Womens Health Services of Central Virginia
Lynchburg, Virginia, 24502
Whittney Calohan, 434-485-7059, wcalohan@whscv.com
Wade Neiman
- Recruiting
Reproductive Associates of Delaware (RAD)
Newark, Delaware, 19713
Eileen Davies, edavies@radfertility.com
Ronald Feinberg
- Recruiting
Advanced Women's Care Center
Stockbridge, Georgia, 30281
Kristina Louissaint, 770-538-1723, info@advancedwomenscarecenter.com
Tamika Sea, MD
- Recruiting
Nezhat Surgery for Gynecology/Oncology
Valley Stream, New York, 11581
Sharon Cote, MD, sharon@farrnezhatmd.com
Farr Nezhat, MD
About this study
Official title: Deep Neural Network Stratification for the Use in Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
The goal of this observational study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - "EndoCheck" - as an "aid in diagnosis" for endometriosis and to show validity as a diagnostic test
Read the detailed description
The objective is to confirm the clinical performance (sensitivity and specificity) of EndoCheck when compared to laparoscopic surgical assessment as an "aid in diagnosis" for endometriosis in subjects who present with chronic pelvic pain.
The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively. Secondary endpoints include examining the performance of the test in patients stratified by pain severity and other clinical factors.
- Conditions
- Endometriosis
- Being tested
- Observational study, no intervention
- Keywords
- Endometriosis, Biomarkers, Deep neural network
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, no interventionOther
Observational study, no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively
Measured: 24 months
Secondary outcomes (1)
Performance
Examining the performance of the test in patients stratified by pain severity and other clinical factors.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start12 Jul 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aspira Women's Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Pappas, PhD, Principal investigator, Aspira Women's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245695
- Sponsor's protocol ID
- 12-2021
- Status last verified
- Oct 2026
- First submitted
- 1 Feb 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wykes CB, Clark TJ, Khan KS. Accuracy of laparoscopy in the diagnosis of endometriosis: a systematic quantitative review. BJOG. 2004 Nov;111(11):1204-12. doi: 10.1111/j.1471-0528.2004.00433.x. No abstract available.
PubMed 15521864Gupta D, Hull ML, Fraser I, Miller L, Bossuyt PM, Johnson N, Nisenblat V. Endometrial biomarkers for the non-invasive diagnosis of endometriosis. Cochrane Database Syst Rev. 2016 Apr 20;4(4):CD012165. doi: 10.1002/14651858.CD012165.
PubMed 27094925Revised American Society for Reproductive Medicine classification of endometriosis: 1996. Fertil Steril. 1997 May;67(5):817-21. doi: 10.1016/s0015-0282(97)81391-x. No abstract available.
PubMed 9130884
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Neural Network Stratification for the Use in Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
- ClinicalTrials.gov ID
- NCT05245695
- Acronym / sponsor ID
- 12-2021
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Biomarkers, Deep neural network
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Aspira Women's HealthIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 18 Feb 2022 (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.
The goal of this observational study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - "EndoCheck" - as an "aid in diagnosis" for endometriosis and to show validity as a diagnostic test
Detailed description
The objective is to confirm the clinical performance (sensitivity and specificity) of EndoCheck when compared to laparoscopic surgical assessment as an "aid in diagnosis" for endometriosis in subjects who present with chronic pelvic pain.
The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively. Secondary endpoints include examining the performance of the test in patients stratified by pain severity and other clinical factors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women scheduled for a gynecologic surgery
Key inclusion criteria (3 listed)
- Participant is willing and able to provide written informed consent.
- Participant is a female aged 14 to 50 years old at time of consent.
- Participant is scheduled to undergo laparotomy or laparoscopy for symptomology consistent with possible endometriosis
Key exclusion criteria (8 listed)
- Participant is a female in a pre-menarchal state.
- Participant is pregnant.
- Participant has an active malignancy.
- Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
- Participant has an active pelvic infection or other infections contraindicated for surgery.
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 |
|---|---|---|
| Observational study, no interventionObservational study, no intervention | Other | – |
Primary outcome
Sensitivity and Specificity
Time frame: 24 months
The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively
1 secondary outcome
Performance
Time frame: 24 months
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 28 Oct 2026.
- Background: PubMed 15521864Wykes CB, Clark TJ, Khan KS. Accuracy of laparoscopy in the diagnosis of endometriosis: a systematic quantitative review. BJOG. 2004 Nov;111(11):1204-12. doi: 10.1111/j.1471-0528.2004.00433.x. No abstract available.
- Background: PubMed 27094925Gupta D, Hull ML, Fraser I, Miller L, Bossuyt PM, Johnson N, Nisenblat V. Endometrial biomarkers for the non-invasive diagnosis of endometriosis. Cochrane Database Syst Rev. 2016 Apr 20;4(4):CD012165. doi: 10.1002/14651858.CD012165.
- Background: PubMed 9130884Revised American Society for Reproductive Medicine classification of endometriosis: 1996. Fertil Steril. 1997 May;67(5):817-21. doi: 10.1016/s0015-0282(97)81391-x. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Silvana Franco contact
Todd Pappas, PhD principal investigator
Aspira Women's Health
10 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, run by Aspira Women's Health at 10 sites in United States.
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 3 inclusion and 8 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Contact Marla Then, CRC (844-277-4721, mthen@aspirawh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05245695, which also lists 3 linked publications.
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 28 Oct 2026.