Surgical Sample Collection- Sampling During Uterine Surgery

Completed

• Conditions: Women's Health

• Registration Number: NCT06460818
• Lead Sponsor: PinkDx, Inc.

Brief Summary

The goal of this clinical trial is to evaluate anatomical locations for sample collection for future decisions for diagnostic test development.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-27
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-14
• Status Verified: 2024-11
• Primary Completion: 2024-11-29
• Study Completion: 2024-11-29
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 234

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent form (ICF) indicating that the participant has been informed of all pertinent aspects of the study.

2. Willing and able to comply with scheduled visits, investigational plan, and other procedures.

3. Females:

   1. Aged >45 for benign and pre-malignant cases
   2. Aged >18 with positive biopsies.

4. Presence of uterus.

5. Scheduled for hysterectomy.

Exclusion Criteria

1. Investigator site staff members directly involved in the conduct of the study and their family members or participants who are Pink Dx, Inc. employees or their family members.
2. Other acute or chronic medical or psychiatric conditions that would increase the risk associated with study participation in the judgement of the investigator.
3. Women who have undergone a hysterectomy.
4. Inability or unwillingness to sign informed consent.
5. Contraindication to surgery, including pregnancy.
6. Women who have used a tampon within 7 days of surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with optimal vaginal samples obtained during the collection process	9 months	Number of participants with optimal vaginal samples obtained during the collection process, including preferred anatomical location and yields and quality of samples.

Trial Locations

Locations (3)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Columbia University; 🇺🇸 New York, New York, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States