Surgical Sample Collection- Sampling During Uterine Surgery

Women's Health Clinical Trial

Official title:

Surgical Sample Collection- Sampling During Uterine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06460818
• Other study ID #: PNK001
• Status: Recruiting
• Start date: February 27, 2024
• Est. completion date: November 29, 2024

Study information

• Verified date: June 2024
• Source: PinkDx, Inc.
• Contact: VP, Clinical Operations
• Phone: 463-273-7024
• Email: devon[@]pinkdx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: November 29, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Women's Health

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
PinkDx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with optimal vaginal samples obtained during the collection process	Number of participants with optimal vaginal samples obtained during the collection process, including preferred anatomical location and yields and quality of samples.	9 months