Fecal IncontinenceNCT02875665
Feasibility Study of the Use of the gekoTM Device for Faecal Incontinence in Older People Living at Home or in Care Homes
A study testing geko(TM) device in people with Fecal Incontinence, run by Firstkind Ltd at 1 site in United Kingdom.
Trial summary
This research aims to investigate the feasibility for the treatment of OnPulse(TM) for the treatment of faecal incontinence (FI) (including mixed faecal and urinary incontinence) in older people living at home or in a Care Home. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- geko(TM) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- Aged 60 and over?
- Reporting faecal incontinence of any severity
- Living in own home or a Care Home
- Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
- Able and willing to follow the protocol requirements.
Who cannot join
- Patients or Carers unable to speak, read or understand English
- Patients or Carers unable to give informed consent because of lack of capacity
- Patients with leg conditions (such as a venous ulcer) that would preclude placement of the gekoTM device.
- Have implantable electronic devices
- Has sore, infected or inflamed areas, broken skin or skin eruptions for example phlebitis, thrombophlebitis, venous leg ulcers, varicose veins etc. in the region where the device would be fitted.
- Any cancerous lesions in the lower limb
- Is pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sussex Community NHS Foundation Trust
Brighton, East Sussex, BN2 3EW
About this study
This research aims to investigate the feasibility for the treatment of OnPulse(TM) for the treatment of faecal incontinence (FI) (including mixed faecal and urinary incontinence) in older people living at home or in a Care Home. It will determine patient acceptability, tolerability and usability of the T-2 gekoTM device for FI by assessing:
- device user factors: acceptability of use, ease of device placement, ease of device interface control and understanding of device instructions;
- tolerability of device: skin tolerability.
- Conditions
- Fecal Incontinence
- Being tested
- geko(TM) device
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geko(TM) deviceDevice
The geko(TM) device will be used to electrically stimulate the posterior tibial nerve
| Study group | Role | What they receive |
|---|---|---|
| geko device arm | Experimental | geko™ devices (acting on the posterior tibial nerve) to be used on alternate days over seven days, for an hour per day Receives: Device: geko(TM) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reviewing the views of older people with faecal incontinence and their formal and informal carers on using the CE marked gekoTM tibial nerve stimulator device in their place of usual residence with regards to ease of use of the device and tolerability.
Using semi-structured interview style with a topic guide pre and post treatment with gekoTM device- researching the views of the patients using their own words to describe what they felt using geko device. Interviews will be digitally recorded and professionally transcribed through verbatim. Data will be anonymised and analysed using a pragmatic thematic analysis (1). NVivo will be used to support the analysis.
Measured: 1 week
Secondary outcomes (2)
Studying the feasibility of older people or their carers applying the device
Interviews performed post treatment will measure this aspect of the study
Measured: 1 week
Skin reactions to using the device on the leg of older people measured by clinical examination
digital photos will be takes pre and post treatment with geko TM device. The digital photos will be viewed in random order from each participant by a second researcher blinded as to before or after status, and rated for signs of skin reaction using the categories: none, mild, moderate and severe.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention is the using geko device
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Norton, Prof, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875665
- Sponsor's protocol ID
- FKD-SBRI-001
- Status last verified
- Feb 2018
- First submitted
- 11 May 2016
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Use of the gekoTM Device for Faecal Incontinence in Older People Living at Home or in Care Homes
- ClinicalTrials.gov ID
- NCT02875665
- Acronym / sponsor ID
- FKD-SBRI-001
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aims to investigate the feasibility for the treatment of OnPulse(TM) for the treatment of faecal incontinence (FI) (including mixed faecal and urinary incontinence) in older people living at home or in a Care Home. It will determine patient acceptability, tolerability and usability of the T-2 gekoTM device for FI by assessing:
- device user factors: acceptability of use, ease of device placement, ease of device interface control and understanding of device instructions;
- tolerability of device: skin tolerability.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention is the using geko device
| Arm | Type | Receives |
|---|---|---|
| geko device arm | Experimental | Device: geko(TM) devicegeko™ devices (acting on the posterior tibial nerve) to be used on alternate days over seven days, for an hour per day |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female
- Aged 60 and over?
- Reporting faecal incontinence of any severity
- Living in own home or a Care Home
- Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
Key exclusion criteria (7 listed)
- Patients or Carers unable to speak, read or understand English
- Patients or Carers unable to give informed consent because of lack of capacity
- Patients with leg conditions (such as a venous ulcer) that would preclude placement of the gekoTM device.
- Have implantable electronic devices
- Has sore, infected or inflamed areas, broken skin or skin eruptions for example phlebitis, thrombophlebitis, venous leg ulcers, varicose veins etc. in the region where the device would be fitted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| geko(TM) deviceThe geko(TM) device will be used to electrically stimulate the posterior tibial nerve | Device | geko device arm |
Primary outcome
Reviewing the views of older people with faecal incontinence and their formal and informal carers on using the CE marked gekoTM tibial nerve stimulator device in their place of usual residence with regards to ease of use of the device and tolerability.
Time frame: 1 week
Using semi-structured interview style with a topic guide pre and post treatment with gekoTM device- researching the views of the patients using their own words to describe what they felt using geko device. Interviews will be digitally recorded and professionally transcribed through verbatim. Data will be anonymised and analysed using a pragmatic thematic analysis (1). NVivo will be used to support the analysis.
2 secondary outcomes
Studying the feasibility of older people or their carers applying the device
Time frame: 1 week
Skin reactions to using the device on the leg of older people measured by clinical examination
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Norton, Prof principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing geko(TM) device in people with Fecal Incontinence, run by Firstkind Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reviewing the views of older people with faecal incontinence and their formal and informal carers on using the CE marked gekoTM tibial nerve stimulator device in their place of usual residence with regards to ease of use of the device and tolerability. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.