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Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)

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ClinicalTrials.gov Identifier: NCT05245695
Recruitment Status : Recruiting
First Posted : February 18, 2022
Last Update Posted : February 16, 2024
Sponsor:
Information provided by (Responsible Party):
Aspira Women's Health

Tracking Information
First Submitted Date February 1, 2022
First Posted Date February 18, 2022
Last Update Posted Date February 16, 2024
Actual Study Start Date July 12, 2022
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2022)		 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 8, 2022)		 Performance [ Time Frame: 24 months ]
Examining the performance of the test in patients stratified by pain severity and other clinical factors.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Official Title Deep Neural Network Stratification for the Use in Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Brief 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
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum Cell-free DNA
Sampling Method Probability Sample
Study Population Women scheduled for a gynecologic surgery
Condition Endometriosis
Intervention Other: Observational study, no intervention
Observational study, no intervention
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 8, 2022)		 600
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2024
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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 secondary to chronic pain associated with suspected endometriosis.

Exclusion Criteria:

  • Participant has a history of surgically determined diagnosis of endometriosis (either via visual inspection or histopathology).
  • 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 14 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Silvana Franco 844-277-4721 sfranco@aspirawh.com
Contact: Allison Jarosz ajarosz@aspirawh.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05245695
Other Study ID Numbers 12-2021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Aspira Women's Health
Original Responsible Party Same as current
Current Study Sponsor Aspira Women's Health
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Todd Pappas, PhD Aspira Women's Health
PRS Account Aspira Women's Health
Verification Date February 2024