Trials Sponsors Conditions Drugs Pricing

Conditions

Diagnosis Vagina Disease

Outcome Measures

Primary Outcomes (1)

The primary objective is to explore the feasibility of collecting an assessable vaginal sample using the OriCol™ Sampling Device.
Quantification of human DNA retrieved.
Within 3 months of completion of recruitment

Secondary Outcomes (3)

Acceptability of the sampling technique to both patient and clinician
Immediate from test performance
To understand the balloon volume (maximum 80ml) required for effective intra-vaginal sampling.
Within 3 months
Participant feedback during and after the test for using the OriCol™ Sampling Device using a Visual Analogue Scale
Immediate from test performance

Interventions

Quantification of human DNA retrieved and DNA fragmentation profile.Diagnostic test

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 99 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsAs an intravaginal examination technique, the presence of a natural vagina is required.

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients will be enrolled until 40 samples have been collected and confirmed assessable by the sponsor. Estimated that 45 recruits will be required to collect 40 assessable samples. For this study, 40 Participant samples will be sufficient to fulfil the objectives of the clinical study. The aim is to obtain a variety of samples from pre-, peri- and post-menopausal women to understand if the change in menopausal status affects device acceptability.

You may qualify if:

Sponsors & Collaborators

Origin Sciences
Industrylead
Royal Infirmary of Edinburgh
Othercollaborator

Study Sites (1)

The Queens Medical Research Institute

Edinburgh, Scotland, EH16 4TJ, United Kingdom

Biospecimen

Retention: SAMPLES WITH DNA

The hydrophilic membrane on the Oricol device allows collection of material from the wall of the vagina including vaginal mucus for analysis.

MeSH Terms

Conditions

Vaginal DiseasesDisease

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Andrew Horne, PhD MRCOG
Edinburgh Royal Infirmary
PRINCIPAL INVESTIGATOR

Enrollment

45 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 1 Day
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 1, 2023

Study Start

January 11, 2024

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations