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NCT07413822: TIES IV
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
NA trial testing TIES® Transcutaneous Implant Evacuation System in Ileostomy - Stoma in 10 participants. Not yet recruiting.
30 May 2027
Quick facts
| Lead sponsor | Asian Institute of Gastroenterology, India |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 10 |
| Start date | 1 March 2026 |
| Primary completion | 30 May 2027 |
| Estimated completion | 30 May 2028 |
Drugs / interventions tested
- TIES® Transcutaneous Implant Evacuation System
Conditions studied
- Ileostomy - Stoma — all drugs for Ileostomy - Stoma →
- Colostomy - Stoma — all drugs for Colostomy - Stoma →
Sponsor
Asian Institute of Gastroenterology, India
Who can join
Adults 18 to 75, any sex, with Ileostomy - Stoma or Colostomy - Stoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07413822
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Asian Institute of Gastroenterology, India trials
Trials by the same sponsor.
- NCT07486518 — A Multicentre Prospective Cohort Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy An · not yet recruiting
- NCT07399652 — Artificial Intelligence-Guided Detection of Blood Vessels to Enhance Safety in Third-Space Endoscopic Procedures · NA · recruiting
- NCT07371832 — A Single Center Evaluation of AI Enabled SureForm Robotic Stapler (SureformTM) Compared to Conventional Stapler for Colo · recruiting
- NCT07329816 — External, Multicentre Validation of a Machine-Learning Model to Predict Colonic Adenoma in Indian Adults · not yet recruiting
- NCT07329803 — Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07413822 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Asian Institute of Gastroenterology, India
- Last refreshed: 17 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07413822.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing