Clinical Trials in Spain / NCT06042205
Active, not recruiting
Not applicable
TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study
NCT06042205 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Hernia
Investigational drug(s) / intervention(s)
TISSIUM™ Atraumatic Hernia Repair System (TAHRS)
TISSIUM™ Atraumatic Hernia Repair System (TAHRS): The TAHRS is intended for fixation of prosthetic material to soft tissue
Study summary
The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS
Eligibility
Key Inclusion Criteria:
1. Subject is 18 years old or older;
2. Patient willing and able to provide a signed Patient Informed Consent Form;
3. Has a midline primary ventral, umbilical or incisional hernia;
4. Scheduled for a laparoscopic IPOM hernia repair;
5. Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect
Key Exclusion Criteria:
1. Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures);
2. BMI \> 40;
3. Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day;
4. Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent;
5. Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding;
6. Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus;
7. Patient has more than one hernia defect (to be confirmed intraoperatively);
Primary outcome measure(s)
- Serious Adverse Device Effect (SADEs) — through 12 months post-surgery
Cumulative incidence of complications (CIC) related to the TAHRS including: Infection, Chronic pain, Recurrence of hernia, Impaired/delayed healing at the surgical site(s), Allergic reaction/hypersensitivity reaction,
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Ziekenhuis Oost-Limburg [ZOL] | Genk | Limburg | |
| Imelda Hospital | Bonheiden | Belgium | |
| AZ Sint-Jan | Ruddershove | Belgium | |
| CHU UCL Namur | Yvoir | Belgium | |
| Universitary Hospital Virgen Macarena | Seville | Spain |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06042205 on ClinicalTrials.gov ↗ ← All trials in Spain