Ileostomy - StomaNCT03416023
Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy
A study testing TIES® (Transcutaneous Implant Evacuation System) in people with Ileostomy - Stoma, run by Ostomycure AB at 4 sites in 2 countries.
Trial summary
Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- TIES® (Transcutaneous Implant Evacuation System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 30 Oct 2018to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has ulcerative colitis, familial adenomatous polyposis coli or other diseases such as Crohn´s disease for whom a permanent ileostomy is indicated; or the subject has a medical need for an alternative to an existing conventional end-ileostomy, continent ileostomy or pelvic pouch; and
- Patient is a male ≥18 years of age or female ≥18 years of age (See exclusion criterion 4 regarding female with childbearing potential); and
- Signed written informed consent has been obtained prior to any study- related procedure.
Who cannot join
- Concurrent gastrointestinal fistula, parastomal or incisional hernia, or a history of recurrent gastrointestinal fistula, recurrent parastomal hernia(s), and/or recurrent incisional hernia(s).
- Patients with undetermined colitis.
- An acute episode of Crohn´s disease occurring during the last three months before the operation
- Females who are of childbearing potential and do not wish to use birth control measures for the duration of the study
- Patients receiving immunosuppressives, oncologic treatment or anticoagulants.
- Any clinically significant, abnormal, baseline laboratory result which in the opinion of the surgeon, affects the patient's suitability for the study or puts the patient at risk if he/she undergoes surgery
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- Severe illness which, in the opinion of the surgeon may put the patient at risk when participating in the study or may affect the patient's ability to complete the study visits
- Condition associated with the risk of poor protocol compliance, e.g. alcoholism and/or drug abuse, dementia, self-destructive personality disorder
- Subjects with BMI ≤ 17 kg/m2 or BMI ≥ 33 kg/m2
- Participate in other clinical studies that could interfere with the result in the ongoing study
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Sweden2 sites
Gothenburgs University Hospital
Gothenburg
Linköpings University Hospital
Linköping
United Kingdom2 sites
St James' University Hospital
Leeds, LS9 7TF
University Hospitals Plymouth NHS Trust
Plymouth, PL6 5FP
About this study
Official title: Prospective Multicentre Open Clinical Study to Assess the Safety Performance and Durability of the TIES® Transcutaneous Titanium Implant in Patients Requiring a Permanent Ileostomy
Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.
Read the detailed description
This is a multicentre, open-label, single-arm clinical study that will assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy (a surgical procedure that involves connecting the small intestine to the skin to create an opening).
The Transcutaneous Implant Evacuation System (TIES®) is a medical device designed to enable continence control for patients who would otherwise need to wear an ileostomy bag.
Eligible subjects will undergo a conventional ileostomy procedure under general anaesthesia and have the TIES® Port implanted. To date, the TIES® has been evaluated in 11 patients in 2 clinical studies. This study aims to collect more data that will assess performance, durability, safety and the impact that the TIES® has on a patient's quality of life.
The study will enroll 50 patients across Europe that require a permanent ileostomy, including patients with ulcerative colitis, familial adenomatous polyposis coli or other diseases such as Crohn´s disease.
Study subjects are expected to participate for approximately 1 year following surgical placement of the TIES® Port. Participation will involve a screening period, surgical implantation of the device (in-patient) and scheduled follow-up assessments out to 1 year post implant.
- Conditions
- Ileostomy - Stoma
- Being tested
- TIES® (Transcutaneous Implant Evacuation System)
- Keywords
- Implant, continence control, titanium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIES® (Transcutaneous Implant Evacuation System)Device
Transcutaneous Implant Evacuation System
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | Not described Receives: Device: TIES® (Transcutaneous Implant Evacuation System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Visible Leakage or Fecal Staining of Clothing at 24 Weeks
Absence of visible leakage or fecal staining of clothing at 24 weeks after implantation of the TIES® Port.
Measured: 24 weeks after implantation of the TIES® Port
Secondary outcomes (12)
Absence of Visible Leakage or Fecal Staining of Clothing at 16 Weeks
Absence of visible leakage or fecal staining of clothing at 16 weeks assessed in a diary
Measured: 16 weeks
Absence of Visible Leakage or Fecal Staining of Clothing 36 Weeks
Absence of visible leakage or fecal staining of clothing at 36 weeks assessed in a diary
Measured: 36 weeks
Absence of Visible Leakage or Fecal Staining of Clothing at 52 Weeks
Absence of visible leakage or fecal staining of clothing at 52 weeks assessed in a diary
Measured: 52 weeks
Proportion of Implanted Subjects Using the TIES Lid at 16 Weeks
Proportion of implanted subjects using the TIES Lid for continence control at 16 weeks
Measured: 16 weeks
Proportion of Implanted Subjects Using the TIES Lid at 24 Weeks
Proportion of implanted subjects using the TIES Lid for continence control at 24 weeks
Measured: 24 weeks
Proportion of Implanted Subjects Using the TIES Lid at 36 Weeks
Proportion of implanted subjects using the TIES Lid for continence control at 36 weeks
Measured: 36 weeks
Proportion of Implanted Subjects Using the TIES Lid at 52 Weeks
Proportion of implanted subjects using the TIES Lid for continence control at 52 weeks
Measured: 52 weeks
Subject's Preferences Regarding Maintaining Body Hygiene
Number of subjects who found it easier using the TIES® Lid than using stoma bags for periodic emptying of waste
Measured: 52 weeks
Subject's Preferences Regarding Daily Activities
Number of subjects who found it easier using the TIES® Lid than using stoma bags for periodic emptying of waste
Measured: 52 weeks
Subject's Preferences: Being Worried About Odor From Stoma
Number of subjects who were less worried when using the TIES® Lid than when using stoma bags for periodic emptying of waste
Measured: 52 weeks
Subject's Preferences: Being Worried About Leakage From Stoma
Number of subjects who were less worried when using the TIES® Lid than when using stoma bags for periodic emptying of waste
Measured: 52 weeks
Subject's Preferences: Recommending the TIES Solution
Number of subjects who would recommend the TIES solution to friends or family who need to undergo ileostomy
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start30 Oct 2018
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Why it stopped: The decision to halt the study is due to a discovered discrepancy between the study design and the anticipated use of the TIES product system. A new study will be launched during late 2024.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ileostomy - StomaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-arm multicentre open clinical study
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostomycure AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Devicia AB (now part of Veranex)
- Responsible party
- Sponsor
- Investigators
- Ludvig Linton, PhD, Study director, OstomyCure AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416023
- Sponsor's protocol ID
- TIES® III C03
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2018
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently no plan to share IPD but OstomyCure would be open to requests
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Open Clinical Study to Assess the Safety Performance and Durability of the TIES® Transcutaneous Titanium Implant in Patients Requiring a Permanent Ileostomy
- ClinicalTrials.gov ID
- NCT03416023
- Acronym / sponsor ID
- TIES® III C03
- Conditions
- Ileostomy - Stoma
- Keywords
- Implant, continence control, titanium
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to halt the study is due to a discovered discrepancy between the study design and the anticipated use of the TIES product system. A new study will be launched during late 2024.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ostomycure ABIndustry (pharma, biotech, devices)
- Collaborators
- Devicia AB (now part of Veranex)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Posted 17 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.
Detailed description
This is a multicentre, open-label, single-arm clinical study that will assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy (a surgical procedure that involves connecting the small intestine to the skin to create an opening).
The Transcutaneous Implant Evacuation System (TIES®) is a medical device designed to enable continence control for patients who would otherwise need to wear an ileostomy bag.
Eligible subjects will undergo a conventional ileostomy procedure under general anaesthesia and have the TIES® Port implanted. To date, the TIES® has been evaluated in 11 patients in 2 clinical studies. This study aims to collect more data that will assess performance, durability, safety and the impact that the TIES® has on a patient's quality of life.
The study will enroll 50 patients across Europe that require a permanent ileostomy, including patients with ulcerative colitis, familial adenomatous polyposis coli or other diseases such as Crohn´s disease.
Study subjects are expected to participate for approximately 1 year following surgical placement of the TIES® Port. Participation will involve a screening period, surgical implantation of the device (in-patient) and scheduled follow-up assessments out to 1 year post implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-arm multicentre open clinical study
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Device: TIES® (Transcutaneous Implant Evacuation System) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has ulcerative colitis, familial adenomatous polyposis coli or other diseases such as Crohn´s disease for whom a permanent ileostomy is indicated; or the subject has a medical need for an alternative to an existing conventional end-ileostomy, continent ileostomy or pelvic pouch; and
- Patient is a male ≥18 years of age or female ≥18 years of age (See exclusion criterion 4 regarding female with childbearing potential); and
- Signed written informed consent has been obtained prior to any study- related procedure.
Key exclusion criteria (10 listed)
- Concurrent gastrointestinal fistula, parastomal or incisional hernia, or a history of recurrent gastrointestinal fistula, recurrent parastomal hernia(s), and/or recurrent incisional hernia(s).
- Patients with undetermined colitis.
- An acute episode of Crohn´s disease occurring during the last three months before the operation
- Females who are of childbearing potential and do not wish to use birth control measures for the duration of the study
- Patients receiving immunosuppressives, oncologic treatment or anticoagulants.
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 |
|---|---|---|
| TIES® (Transcutaneous Implant Evacuation System)Transcutaneous Implant Evacuation System | Device | Single |
Primary outcome
Absence of Visible Leakage or Fecal Staining of Clothing at 24 Weeks
Time frame: 24 weeks after implantation of the TIES® Port
Absence of visible leakage or fecal staining of clothing at 24 weeks after implantation of the TIES® Port.
12 secondary outcomes
Absence of Visible Leakage or Fecal Staining of Clothing at 16 Weeks
Time frame: 16 weeks
Absence of Visible Leakage or Fecal Staining of Clothing 36 Weeks
Time frame: 36 weeks
Absence of Visible Leakage or Fecal Staining of Clothing at 52 Weeks
Time frame: 52 weeks
Proportion of Implanted Subjects Using the TIES Lid at 16 Weeks
Time frame: 16 weeks
Proportion of Implanted Subjects Using the TIES Lid at 24 Weeks
Time frame: 24 weeks
Proportion of Implanted Subjects Using the TIES Lid at 36 Weeks
Time frame: 36 weeks
Proportion of Implanted Subjects Using the TIES Lid at 52 Weeks
Time frame: 52 weeks
Subject's Preferences Regarding Maintaining Body Hygiene
Time frame: 52 weeks
Subject's Preferences Regarding Daily Activities
Time frame: 52 weeks
Subject's Preferences: Being Worried About Odor From Stoma
Time frame: 52 weeks
Subject's Preferences: Being Worried About Leakage From Stoma
Time frame: 52 weeks
Subject's Preferences: Recommending the TIES Solution
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Currently no plan to share IPD but OstomyCure would be open to requests
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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.
Ludvig Linton, PhD study director
OstomyCure AS
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIES® (Transcutaneous Implant Evacuation System) in people with Ileostomy - Stoma, run by Ostomycure AB at 4 sites in 2 countries.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, 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?
Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absence of Visible Leakage or Fecal Staining of Clothing at 24 Weeks (time frame: 24 weeks after implantation of the TIES® Port). 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 11 Mar 2025.