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OpenTrials
Completed

NCT Number: NCT06460818

Surgical Sample Collection- Sampling During Uterine Surgery

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

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Key information

Conditions

Women's Health

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Willing and able to comply with scheduled visits, investigational plan, and other procedures.
  • Females:
  • Aged >45 for benign and pre-malignant cases
  • Aged >18 with positive biopsies.
  • Presence of uterus.
  • Scheduled for hysterectomy.

Exclusion criteria

  • 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.
  • Other acute or chronic medical or psychiatric conditions that would increase the risk associated with study participation in the judgement of the investigator.
  • Women who have undergone a hysterectomy.
  • Inability or unwillingness to sign informed consent.
  • Contraindication to surgery, including pregnancy.
  • Women who have used a tampon within 7 days of surgery.

Treatment and study plan

Primary outcomes

  1. Number of participants with optimal vaginal samples obtained during the collection process

    Time frame: 9 months

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

Sponsors and collaborators

Lead sponsor

PinkDx, Inc.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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