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Lab-developed Test

Cohort 3 for Endometriosis

Phase 2
Recruiting
Led By Sandra M Hurtado, MD
Research Sponsored by Hera Biotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after laparoscopy
Awards & highlights

Study Summary

This trial is testing a non-surgical way to diagnose endometriosis, by analyzing uterine tissue with lab + AI.

Eligible Conditions
  • Endometriosis
  • Diagnosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week after laparoscopy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week after laparoscopy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Secondary outcome measures

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 3Experimental Treatment1 Intervention
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
Group II: Cohort 2Active Control1 Intervention
Endometriosis diagnosed at stage 3 or 4
Group III: Cohort 1Active Control1 Intervention
Endometriosis diagnosed at stage 1 or 2

Find a Location

Who is running the clinical trial?

Hera Biotech, Inc.Lead Sponsor
Sandra M Hurtado, MDPrincipal InvestigatorUniversity of Texas Physicians Women's Center
Jacqueline A Robinson, MDPrincipal InvestigatorValley OB-GYN Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study recruiting individuals aged 45 or older?

"This medical study stipulates that the minimum age for eligibility is 18 and the cut-off age is 50."

Answered by AI

What safety considerations have been made for Cohort 1 participants?

"The safety of Cohort 1 was rated a 2 on our internal scale, as this is Phase 2 trial and there has only been evidence confirming the former with no reported success on efficacy."

Answered by AI

What is the current cohort size of this investigation?

"Affirmative. According to clinicaltrials.gov, the medical study was initially posted on September 14th 2022 and is currently in search of 75 patients from 3 separate sites. The trial was last edited on January 24th 2023."

Answered by AI

Is there still an opportunity to sign up for the experiment?

"Affirmative, the information hosted on clinicaltrials.gov implies that this research is actively recruiting patients. It was originally published on September 14th 2022 and updated most recently on January 24th 2023. The trial requires 75 participants from 3 different sites to participate in it."

Answered by AI

What criteria must applicants meet in order to be eligible for this research effort?

"This medical trial is searching for 75 volunteers, aged 18-50 years old and suffering from endometriosis. To be considered eligible to participate in this study one must have the capacity to provide informed consent, naturally identify as female and not pregnant at Visit 0 or 1, free of any systemic illness that may influence the tissue collection procedure; no excision/ablation procedures within a year prior to screening visit (Visit 0); suspected of having endometriosis or previously diagnosed with it and recommended laparoscopic surgery by physician; scheduled for laparoscopy 60 days after screening visit (Visit 0) after obtaining biopsy on first"

Answered by AI

Who else is applying?

What state do they live in?
Ontario
What site did they apply to?
Valley OB-GYN Clinic, PC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

~29 spots leftby Apr 2025