EndometriosisPhase 2NCT05698212
Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
A Phase 2 study testing MetriDx in people with Endometriosis and Diagnosis, run by Hera Biotech, Inc. at 3 sites in United States.
Trial summary
This study is testing a way to diagnose endometriosis using a uterine tissue biopsy (similar to a pap smear) as opposed to undergoing laparoscopy surgery. The tissue is sent to lab for cellular analysis with a proprietary AI (artificial intelligence) technology. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Diagnosis
- What is being tested?
- MetriDx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Sep 2022to 10 Apr 2023
- Phase
- Phase 2
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand and provide informed consent.
- Natural born female of childbearing potential.
- Age between 18 and 50, inclusive.
- Not pregnant at Visit 0 (screening) or Visit 1 (day of procedure).
- Free of systemic or pelvic disorder that, in the opinion of the investigator, may interfere with the tissue collection procedure, analysis of the tissue or increase the risk to subject.
- Must not have received excision or ablation surgical procedure or treatment, such as gonadotropin-releasing hormone (GnRH), for endometriosis within the past 12 months.
Show all 16Show fewer
- For Cohort 1 and 2:
- Suspected of having endometriosis, or previously diagnosed with endometriosis, and currently recommended for laparoscopic surgery by physician.
- Must have laparoscopic surgery within 60 days after screening Visit 0 and any time after the endometrial biopsy is obtained on Visit 1 (including the same day), or a laparoscopy on record within the 12 months prior to Visit 0 for diagnosis only.
- Surgical report from prior laparoscopy must indicate that endometriosis was not treated with surgical ablation or excision.
- Subjects will be assigned to Cohort 1 or 2 based on diagnosis and staging results from laparoscopy.
- Or for Cohort 3:
- Not suspected of having endometriosis
- no previous diagnosis or symptoms of endometriosis, who have had a laparoscopy for another reason, such as tubal ligation or other abdominal procedure, within the past 12 months prior to screening Visit 0,
- or laparoscopy to be completed within 60 days after screening Visit 0 and any time after the endometrial biopsy is obtained on Visit 1 (including the same day).
- Surgeon's report must have no supplemental observations of endometriosis lesions or diagnosis. Subjects will be assigned to Cohort 3.
Who cannot join
- Younger than 18 or 51 years or older.
- Surgical history of hysterectomy.
- Has received excision or ablation surgical procedure or treatment, such as gonadotropin-releasing hormone (GnRH), for endometriosis within the past 12 months.
- Cohort 3: Prior diagnosis of endometriosis, or surgical note from prior laparoscopy that indicates endometriosis lesions were observed.
- Has a BMI 40 or above.
- Is currently taking a blood thinner medication.
Show all 16Show fewer
- Currently, pregnant, breast feeding, or has given birth in the last 6 months.
- Diagnosed with HIV, AIDS, hepatitis A, B, or C, or has active malignancy.
- Has a complicating condition that would pose a hazard to tissue handling.
- Undergoing fertility or hormone therapy treatments.
- History or evidence of uterine fibroids.
- History of reproductive cancer.
- Has a condition that, in the opinion of the investigator, would confound tissue collection or analysis.
- Has an active pelvic infection or other infections contra-indicated for laparoscopy.
- Has participated in any interventional clinical trial in the previous 90 days in which an investigational drug was administered.
- Has a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past two years.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Corpus Christi Women's Center
Corpus Christi, Texas, 78412
Jessica Sanchez, 361-851-5000, Jessica.sanchez@elligodirect.com
Monica Marroquin, 361-851-5000, monica.marroquin@elligodirect.com
- Recruiting
University of Texas Physician's Women's Center--Memorial City
Houston, Texas, 77024
Lori L Wink, MSN, NP, 706-251-8339, lori.L.wink@uth.tmc.edu
Sandry Hurtago, MD
- Not yet recruiting
Valley OB-GYN Clinic, PC
Saginaw, Michigan, 48602
Mackenzie Rittenberg, 989-753-8453, mackenzie.rittenberg@elligodirect.com
Jackie Lang, 989-753-8453, jacqueline.lang@elligodirect.com
About this study
Official title: Proof-of-Concept, Obs Study to Evaluate Accuracy of MetriDx Lab Developed Test (LDT) to Accurately Identify Endometriosis-specific Biological Markers Using Micro-fluidic Analysis of Cells Enabling Clinicians to Diagnose Endometriosis
This study is testing a way to diagnose endometriosis using a uterine tissue biopsy (similar to a pap smear) as opposed to undergoing laparoscopy surgery. The tissue is sent to lab for cellular analysis with a proprietary AI (artificial intelligence) technology.
Read the detailed description
This study involves 2 visits to the site and possibly as outpatient surgical center, and the participant will be involved in the for as little as 1 day to as much as 60 days, mainly depending on scheduling of laparoscopy. Eligible participants in the active group will have history of endometriosis and will be having a laparoscopy for diagnosis within the next few weeks. Eligible participants in the control group will have no history of endometriosis but will need or have recently had a laparoscopy surgical procedure for a reasons such as tubal ligation.
The participant will have an uterine biopsy (similar to a pap smear) in the physician's office before the laparoscopy. The biopsied tissue will be sent to a special lab for analysis and diagnosis of endometriosis by an innovative proprietary procedure that analyses the cells of the tissue collected in the biopsy.
The results of the biopsy will be compared to the laparoscopy for accuracy.
- Conditions
- Endometriosis, Diagnosis
- Being tested
- MetriDx
- Keywords
- endometriosis, MetriDx, connexins, biological markers, micro-fluidic analysis, uterine tissue biopsy
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetriDxDiagnostic test
Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Endometriosis diagnosed at stage 1 or 2 Receives: Diagnostic Test: MetriDx |
| Cohort 2 | Active comparator | Endometriosis diagnosed at stage 3 or 4 Receives: Diagnostic Test: MetriDx |
| Cohort 3 | Other | Control--Not suspected of having and absence of endometriosis confirmed by diagnostic test.
This group has uterine tissue biopsy and laparoscopy for non-endometriosis indication, i.e. tubal ligation Receives: Diagnostic Test: MetriDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Endometriosis diagnosis
Measured: 1 week after laparoscopy
Secondary outcomes (2)
Secondary Outcome
Accurate staging of endometriosis
Measured: 1 week after laparoscopy
Tertiary Outcome
observe and explore any relationship between subject's estrogen and progesterone levels and MetriDx results.
Measured: 1 week after providing menstrual effluent sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start14 Sep 2022
- Primary completion25 Mar 2023 (estimated)
- Study completion10 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two cohorts defined by confirmed diagnosis of endometriosis and further grouping by staging of endometriosis A third cohort of control participants who have not been suspected or diagnosed with endometriosis
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hera Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra M Hurtado, MD, Principal investigator, University of Texas Physicians Women's CenterCharles R Kirkham, MD, Principal investigator, Corpus Christi Women's ClinicJacqueline A Robinson, MD, Principal investigator, Valley OB-GYN Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698212
- Sponsor's protocol ID
- HER001
- Status last verified
- Nov 2022
- First submitted
- 29 Nov 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Concept, Obs Study to Evaluate Accuracy of MetriDx Lab Developed Test (LDT) to Accurately Identify Endometriosis-specific Biological Markers Using Micro-fluidic Analysis of Cells Enabling Clinicians to Diagnose Endometriosis
- ClinicalTrials.gov ID
- NCT05698212
- Acronym / sponsor ID
- HER001
- Conditions
- Endometriosis, Diagnosis
- Keywords
- endometriosis, MetriDx, connexins, biological markers, micro-fluidic analysis, uterine tissue biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hera Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 25 Mar 2023 (estimated)
- Study completion
- 10 Apr 2023 (estimated)
- First posted
- 26 Jan 2023 (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.
This study is testing a way to diagnose endometriosis using a uterine tissue biopsy (similar to a pap smear) as opposed to undergoing laparoscopy surgery. The tissue is sent to lab for cellular analysis with a proprietary AI (artificial intelligence) technology.
Detailed description
This study involves 2 visits to the site and possibly as outpatient surgical center, and the participant will be involved in the for as little as 1 day to as much as 60 days, mainly depending on scheduling of laparoscopy. Eligible participants in the active group will have history of endometriosis and will be having a laparoscopy for diagnosis within the next few weeks. Eligible participants in the control group will have no history of endometriosis but will need or have recently had a laparoscopy surgical procedure for a reasons such as tubal ligation.
The participant will have an uterine biopsy (similar to a pap smear) in the physician's office before the laparoscopy. The biopsied tissue will be sent to a special lab for analysis and diagnosis of endometriosis by an innovative proprietary procedure that analyses the cells of the tissue collected in the biopsy.
The results of the biopsy will be compared to the laparoscopy for accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Two cohorts defined by confirmed diagnosis of endometriosis and further grouping by staging of endometriosis A third cohort of control participants who have not been suspected or diagnosed with endometriosis
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Diagnostic Test: MetriDxEndometriosis diagnosed at stage 1 or 2 |
| Cohort 2 | Active comparator | Diagnostic Test: MetriDxEndometriosis diagnosed at stage 3 or 4 |
| Cohort 3 | Other | Diagnostic Test: MetriDxControl--Not suspected of having and absence of endometriosis confirmed by diagnostic test. This group has uterine tissue biopsy and laparoscopy for non-endometriosis indication, i.e. tubal ligation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Able to understand and provide informed consent.
- Natural born female of childbearing potential.
- Age between 18 and 50, inclusive.
- Not pregnant at Visit 0 (screening) or Visit 1 (day of procedure).
- Free of systemic or pelvic disorder that, in the opinion of the investigator, may interfere with the tissue collection procedure, analysis of the tissue or increase the risk to subject.
Key exclusion criteria (16 listed)
- Younger than 18 or 51 years or older.
- Surgical history of hysterectomy.
- Has received excision or ablation surgical procedure or treatment, such as gonadotropin-releasing hormone (GnRH), for endometriosis within the past 12 months.
- Cohort 3: Prior diagnosis of endometriosis, or surgical note from prior laparoscopy that indicates endometriosis lesions were observed.
- Has a BMI 40 or above.
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 |
|---|---|---|
| MetriDxBiopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record | Diagnostic test | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Primary Outcome
Time frame: 1 week after laparoscopy
Endometriosis diagnosis
2 secondary outcomes
Secondary Outcome
Time frame: 1 week after laparoscopy
Tertiary Outcome
Time frame: 1 week after providing menstrual effluent sample
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 26 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Recruiting
Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.
Endometriosis (Diagnosis)
Not yet recruitingObservational study
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
Endometriosis, Endometriosis Rectum
RecruitingObservational study
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Endometriosis
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
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.
Sandra M Hurtado, MD principal investigator
University of Texas Physicians Women's Center
Charles R Kirkham, MD principal investigator
Corpus Christi Women's Clinic
Jacqueline A Robinson, MD principal investigator
Valley OB-GYN Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MetriDx in people with Endometriosis and Diagnosis, run by Hera Biotech, Inc. at 3 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 16 inclusion and 16 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 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Janan Van Osdell, MHSA (855-826-6638 ext. 102, janan@tammnet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 1 week after laparoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2023.