Ileostomy - StomaTIES IVNCT07413822
A Single-centre Open, Prospective, Pilot Clinical Study to Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy
A study testing TIES® Transcutaneous Implant Evacuation System in people with Ileostomy - Stoma and Colostomy - Stoma, run by Asian Institute of Gastroenterology, India.
Trial summary
This is a single-centre, prospective, open-label pilot clinical study designed to evaluate the safety and performance of the TIES® (Transcutaneous Implant Evacuation System) in adult patients requiring a permanent ileostomy or colostomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ileostomy - Stoma, Colostomy - 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
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Patients requiring a permanent ileostomy or colostomy
- Planned for stoma revision surgery with implantation of the TIES® system
- Ability to understand the study procedures and comply with follow-up visits
- Willingness to provide written informed consent
Who cannot join
- Age below 18 years or above 75 years
- Temporary stoma or planned stoma reversal
- Active abdominal or peristomal infection at the time of surgery
- Severe uncontrolled systemic illness that may increase surgical risk
- Known allergy or hypersensitivity to device materials
- Pregnancy or lactation
- Participation in another interventional clinical study within the last 30 days
- Any condition which, in the opinion of the investigator, makes the patient unsuitable for the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: To Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy
This is a single-centre, prospective, open-label pilot clinical study designed to evaluate the safety and performance of the TIES® (Transcutaneous Implant Evacuation System) in adult patients requiring a permanent ileostomy or colostomy. Eligible patients will undergo surgical implantation of the TIES® Port as part of stoma revision. Participants will be followed for 16 weeks post-implantation to assess device safety, tissue ingrowth and healing, performance, durability, and impact on quality of life. Safety will be evaluated through monitoring of adverse events, while performance and usability will be assessed using structured questionnaires and clinical assessments. Quality of life will be measured using the validated Stoma-QoL questionnaire. The study aims to generate clinical evidence on the feasibility and safety of the TIES® system as an alternative to conventional stoma management.
- Conditions
- Ileostomy - Stoma, Colostomy - Stoma
- Being tested
- TIES® Transcutaneous Implant Evacuation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIES® Transcutaneous Implant Evacuation SystemDevice
The intervention involves surgical implantation of the TIES® Transcutaneous Implant Evacuation System in patients with a permanent ileostomy or colostomy. The device is implanted through the abdominal wall as part of a stoma revision procedure to allow controlled evacuation of bowel contents. Following implantation, participants will be followed up for assessment of device safety, tissue integration, functionality, and patient-reported outcomes over the study period.
| Study group | Role | What they receive |
|---|---|---|
| Single-centre, prospective, open-label, single-arm pilot interventional clinical study | 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.
Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period
Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period
Measured: 16 Weeks
Secondary outcomes (4)
Device performance and functionality, assessed by the ability to achieve controlled evacuation of bowel contents during the study period
Measured: 16 weeks
Durability of the implant, assessed by device integrity and continued use over 16 weeks
Measured: 16 weeks
Patient-reported quality of life, assessed using the Stoma-QoL questionnaire
Measured: 16 weeks
Usability and patient satisfaction, assessed using structured questionnaires
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413822
- Sponsor's protocol ID
- TIES IV
- Acronym
- TIES IV
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy
- ClinicalTrials.gov ID
- NCT07413822
- Acronym / sponsor ID
- TIES IV / TIES IV
- Conditions
- Ileostomy - Stoma, Colostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- 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 is a single-centre, prospective, open-label pilot clinical study designed to evaluate the safety and performance of the TIES® (Transcutaneous Implant Evacuation System) in adult patients requiring a permanent ileostomy or colostomy. Eligible patients will undergo surgical implantation of the TIES® Port as part of stoma revision. Participants will be followed for 16 weeks post-implantation to assess device safety, tissue ingrowth and healing, performance, durability, and impact on quality of life. Safety will be evaluated through monitoring of adverse events, while performance and usability will be assessed using structured questionnaires and clinical assessments. Quality of life will be measured using the validated Stoma-QoL questionnaire. The study aims to generate clinical evidence on the feasibility and safety of the TIES® system as an alternative to conventional stoma management.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-centre, prospective, open-label, single-arm pilot interventional clinical study | Experimental | Device: TIES® Transcutaneous Implant Evacuation System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 75 years
- Patients requiring a permanent ileostomy or colostomy
- Planned for stoma revision surgery with implantation of the TIES® system
- Ability to understand the study procedures and comply with follow-up visits
- Willingness to provide written informed consent
Key exclusion criteria (8 listed)
- Age below 18 years or above 75 years
- Temporary stoma or planned stoma reversal
- Active abdominal or peristomal infection at the time of surgery
- Severe uncontrolled systemic illness that may increase surgical risk
- Known allergy or hypersensitivity to device materials
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 SystemThe intervention involves surgical implantation of the TIES® Transcutaneous Implant Evacuation System in patients with a permanent ileostomy or colostomy. The device is implanted through the abdominal wall as part of a stoma revision procedure to allow controlled evacuation of bowel contents. Following implantation, participants will be followed up for assessment of device safety, tissue integration, functionality, and patient-reported outcomes over the study period. | Device | Single-centre, prospective, open-label, single-arm pilot interventional clinical study |
Primary outcome
Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period
Time frame: 16 Weeks
Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period
4 secondary outcomes
Device performance and functionality, assessed by the ability to achieve controlled evacuation of bowel contents during the study period
Time frame: 16 weeks
Durability of the implant, assessed by device integrity and continued use over 16 weeks
Time frame: 16 weeks
Patient-reported quality of life, assessed using the Stoma-QoL questionnaire
Time frame: 16 weeks
Usability and patient satisfaction, assessed using structured questionnaires
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing TIES® Transcutaneous Implant Evacuation System in people with Ileostomy - Stoma and Colostomy - Stoma, run by Asian Institute of Gastroenterology, India.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DR G V RAO (+91-9182645727, gvraoaig@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period (time frame: 16 Weeks). 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 17 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.