Submitted:
07 October 2025
Posted:
07 October 2025
You are already at the latest version
Abstract
Keywords:
Introduction
Materials and Methods
System Architecture and Design Rationale
Everting Conduit with Progressive Jamming Mechanism
Endoluminal Surgical Instrumentation
Surgical Protocol and Patient Selection
Computational Modeling and Preliminary Validation
3. Results
Structural Performance of Everting Conduit
Surgical Instrumentation Validation
Integrated System Performance
| Parameter | Open Surgery | Laparoscopic | EITRA (Predicted)* |
| Operative Time (min) | 180-240 | 120-180 | 50-80† |
| Blood Loss (mL) | 300-500 | 50-150 | <30† |
| Hospital Stay (days) | 7-10 | 3-5 | 1-2 |
| Anastomotic Leak (%) | 8-12 | 5-8 | <3† |
| Wound Infection (%) | 10-15 | 5-8 | <2 |
| External Incisions | 1 (15-30 cm) | 4-5 (1 cm) | 0 |
3. Discussion
| Phase | Objectives | Duration | Key Outcomes |
| Completed | Proof-of-concept, phantom validation | 12 months | Feasibility demonstration |
| Year 1-2 | Animal studies (porcine), acute outcomes | 18 months | Safety profile, technical refinement |
| Year 2-3 | Animal studies, chronic outcomes | 12 months | Healing validation, long-term patency |
| Year 3-4 | Regulatory submission, first-in-human prep | 12 months | IDE approval, protocol finalization |
| Year 4-5 | First-in-human trial (n=15-30) | 18 months | Safety in humans, protocol optimization |
| Year 5-7 | Comparative trial (n=100-150) | 24 months | Efficacy versus standard care |
| Year 7-8 | Regulatory review, market preparation | 12 months | PMA approval, commercialization |
Conflicts of Interest
References
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