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Surgical Sample Collection- Sampling During Uterine Surgery

Sponsored by PinkDx, Inc.

About this trial

Last updated 5 months ago

Study ID

PNK001

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18 to 99 Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 months ago

What is this trial about?

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

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status

Recruiting
Recruiting
Recruiting