Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05709119 |
| Other study ID # |
Ellele-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 13, 2024 |
| Est. completion date |
June 6, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Origin Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
The female genital tract is comprised of the vagina, cervix, uterine body, fallopian tubes,
and the ovaries. Studies into the dimensions of the vagina have demonstrated there is limited
variation, and such variation are not significantly impacted by parity, body size or
demographics. The length of the vagina differs depending on measuring techniques and whether
the anterior or posterior wall is measured, but on average is between 6 - 10cm in length
(OS012-TR001). Vaginal width varies significantly depending on whether this was measured at
the level of the introitus, in line with the pelvic floor or more proximally within the
tract. Further changes in the vagina are seen in relationship to parity.
As is found in the gastro-intestinal tract, the cervicovaginal tract is, in part, lined with
mucus producing goblet cells. The mucus layer also contains shed epithelial cells, microbes
and various macromolecules, including antibodies (OS012-TR002). The preliminary results of
the colorectal Ori-EGI-02 study, demonstrates that human amplifiable DNA suitable for genomic
and epigenetic analysis can be collected from rectal mucus samples (H. N. Humphrey et al.
2022). The rectal mucus samples are collected using the OriCol™ Sampling device, which is
inserted into the rectum via a standard proctoscope and then by inflation of a nitrile
membrane with 80mL of air.
The current standard examination technique used in gynaecology is a digital vaginal
examination (VE) followed by speculum examination. Speculum examination may be performed in
the left lateral position (using a Sims Speculum) or in lithotomy (using a Cusco's speculum).
Both techniques (and variants) have been in clinical use for over 150 years and allow visual
assessment of the vagina and cervix as well as allowing access for diagnostic and/or
therapeutic procedures.
The current standard diagnostic investigations for cervical, endometrial, and ovarian
malignancy are colposcopy, hysteroscopy, trans-abdominal and trans-vaginal ultrasonography,
or CT scanning. Colposcopy requires the insertion of a bivalve speculum into the vagina to
directly visualise the cervix. In outpatient hysteroscopy, speculum examination is often
carried out to assess the cervix and vagina prior to the procedure. All these investigations
take place within a secondary care setting.
The standard Cusco's speculum is bivalved and in the closed state has a length of 80mm and
width of 22mm. The volume of the closed lubricated speculum passed into the vagina is 36.3cm3
assuming a closed cylinder. Changes in volume will occur with use. One study assessing the
high-pressure zones within the vagina inflated a polyethylene bag of 10cm in length to up to
70cc volume and recorded no adverse effects during the study (OS012-TR001). This suggests
that a medical device of 70cc could be inserted into the vagina for diagnostic purposes
without discomfort for the patient (Jung et al. 2007)
A review was conducted of the standard Intraspec Contour speculum (Robinson Healthcare Ltd),
which is supplied in three sizes: small, medium and large. This was to compare the volume and
dimensions of the speculum with the OriCol™ Sampling Device membrane. Origin Sciences Limited
have taken measurements of the speculums, as a specification from the manufacturer could not
be located.
Due to the characteristics of membrane material of the OriCol™ Sampling Device (PS0025), the
height and width of the balloon when inflated to 80ml of air can vary slightly. Inflated
membrane quality control (QC) checks during manufacturing indicate that the length of the
membrane should not exceed 80mm and the width 63mm. However, the average height of the
inflated membrane is approximately 75.2mm and width of 41.3mm. Although the dimensions of the
membrane fluctuate slightly between devices, the volume of the inflated membrane stays
constant at 65cm3 when inflated with 80mls of air.
The first 40mls of air inserted from the syringe into the membrane push the deflated membrane
out of the device. Air inserted above 40mls start to inflate the membrane. This data suggests
that at approximate maximum volume (65cm3) the OriCol™ Sampling Device inflated membrane has
a smaller volume than a small sized open speculum (~80.9cm3).
There is a current focus on reducing discomfort and increasing compliance in the ability to
obtain samples of disease of the female genital tract (Campaign Against Painful Hysteroscopy:
Open letter to the UK Department of Health & Social Care (20 October 2022)). Hysteroscopy
especially has been the focus on public campaigns to raise awareness of the discomfort
associated with this when performed in the Outpatient Setting. Similarly discomfort during
sampling of the cervix for pre-malignant change has led to interest in the development of an
alternative technology, that is easier to use, has increased patient acceptability and gives
a wider range of results leading to greater clinical benefit. As a minimally invasive test,
it is important that it's use can be replicated easily, achieve very high levels of
compliance, be extremely safe for women and deliver samples that allow high levels of
analysis.
In terms of future health economic benefit, the value of the test is the potential
reproducibility and ease of use in a variety of clinical settings in primary and secondary
care as well as the remote environment.
This feasibility study will address the mechanics of sampling to inform on the technique used
in future larger studies.
