This topic is about the TIES III clinical trial, which was focused on developing a new type of ileostomy implant. The trial was stopped early, and efforts are now shifting towards a new version, TIES IV. Here's a breakdown of what happened and some insights:

- The TIES III trial was a multicenter, open-label, single-arm study designed to test a titanium port system that aimed to provide ileostomy patients with continence without needing an external bag. The trial was sponsored by OstomyCure AS and planned to include 200 participants, but only 28 were enrolled before it was stopped.

- In terms of outcomes, only 8 participants used the TIES Lid at the 24-week mark. Of these, 6 experienced leakage or staining, while 2 remained dry. Early participants, mostly with Crohn’s disease, had issues with tissue ingrowth, leading to the exclusion of Crohn’s patients from future eligibility.

- Quality-of-life improvements were suggested by questionnaires, but the data was limited due to a small sample size and participant drop-outs.

- Safety concerns included 11 device deficiencies, 62 device-related adverse effects in 17 participants, and 23 serious adverse events, with one unexpected case of pyoderma gangrenosum and one unrelated death.

- The trial was stopped, and the data collected is being used to guide the redesign for TIES IV, which is now being developed at University College Hospital London.

- The first recipient of TIES III, who later had the device removed, remains hopeful that TIES IV will benefit future patients and emphasizes the importance of transparent and well-regulated innovation.

Here are some additional insights and advice:

1. Excluding Crohn’s disease patients is considered a necessary safety improvement, although it significantly reduces the potential user base by an estimated 700,000 candidates worldwide.

2. Failure is a normal part of developing medical devices, and ongoing efforts like TIES IV are crucial for progress.

3. The courage of early trial participants is commendable, and their contributions are vital for improving the quality of life for ostomy patients.

4. Maintaining humor and positivity can be helpful when dealing with serious health challenges.

5. The companies involved in this development are OstomyCure AS, the developer and sponsor of the TIES system, and CarpoNovum AAB, a Swedish surgical-instrument company. Prof. Manish Chand, who is leading the TIES IV study, is also the Chief Medical Officer at CarpoNovum AAB.