MedTrace Logo

Feasibility of the Oricol™ Sampling Device to Retrieve Vagina Mucus (Wall) Samples for Genomic & Epigenetic Analysis.

NCT05709119 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2024-10-18

No results posted yet for this study

Summary

Primary Objective

The primary objective is to explore the feasibility of collecting a vaginal sample using the OriCol™ Sampling Device.

Secondary Objectives

The study has secondary objectives to assess:

1. Acceptability of the sampling technique to both patient and clinician
2. To understand the balloon volume (maximum 80ml) required for effective intra-vaginal sampling.
3. Participant feedback during and after the test for using the OriCol™ Sampling Device using a Visual Analogue Scale
4. Patient discrete choice of Oricol™ versus speculum examination.

Conditions

  • Vagina Disease
  • Diagnosis

Interventions

DIAGNOSTIC_TEST

Quantification of human DNA retrieved and DNA fragmentation profile.

The sample will be analysed for material quality and have no impact on the patient's future care.

Sponsors & Collaborators

  • Royal Infirmary of Edinburgh

    collaborator OTHER

  • Origin Sciences

    lead INDUSTRY

Principal Investigators

  • Andrew Horne, PhD MRCOG · Edinburgh Royal Infirmary

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2024-05-30
Completion
2024-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05709119 on ClinicalTrials.gov