TIES III Clinical Trial Stopped: Insights and Future Directions

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Jayne
Jul 16, 2025 2:48 am

I was pleased to be able to read the study report of the previously closed clinical trial of the TIES III 'continent' implant device, which I have copied below courtesy of publishers NHS Health Research Authority.

Prof. Jayne makes the point that as the clinical trial was stopped early—a decision reflecting the need to redesign TIES and continue potentially as a single-arm open study [[it was previously run as a closed study, so little lay patient research was possible into the novel implant device]]—the data must be read with caution.

I am encouraged to see that the redesign of the TIES device to update the product offering version IV of TIES is underway and that a further study—to be run as an open single-arm clinical trial study at University College Hospital London, led by Professor Manish Chand—who is also an investor within the sponsor company and its Chief Clinical & Technical Director (Board Advisor), as well as Honorary Professor and Chief Medical Officer at CarpoNovum AAB—a Swedish company innovating and manufacturing a new generation of surgical instruments for colorectal surgery.

As the first patient to be implanted with TIES III and explanted at Leeds, UK, while my own clinical trial experience was traumatic, I am encouraged to learn that TIES IV is underway—as innovation and transparent research and development are crucial to the more rewarding surgical outcomes for bowel patients.

Accordingly, I am encouraged that, hopefully, with any luck, my own unexpected adverse experience of TIES III will not be revisited upon the future patient body of TIES IV.

Pictures of my abdominal breakdown around the TIES implanted collar are published elsewhere—my patient copyright.

___________________________________________________________________________________________________________________

TIES® C03 Study
Research type
Research Study
Full title
Prospective multicenter open clinical study to assess the safety, performance, and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy
IRAS ID
240457
Contact name
David Jayne
Contact email
d.g.jayne@leeds.ac.uk
Sponsor organization
OstomyCure AS
Duration of study in the UK
1 year, 10 months, 1 day
Research summary
Research Summary:
This is a multicenter, open-label, single-arm clinical study that will assess the safety, performance, and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy (a surgical procedure that involves connecting the small intestine to the skin to create an opening).

The Transcutaneous Implant Evacuation System (TIES®) is a medical device designed to enable continence control for patients who would otherwise need to wear an ileostomy bag.

Eligible subjects will undergo a conventional ileostomy procedure under general anesthesia and have the TIES® Port implanted. To date, the TIES® has been evaluated in 11 patients in 2 clinical studies. This study aims to collect more data that will assess performance, durability, safety, and the impact that the TIES® has on a patient's quality of life.

The study will enroll 50 patients across Europe who require a permanent ileostomy, including patients with ulcerative colitis, familial adenomatous polyposis coli, or other diseases such as Crohn's disease. The NHS will participate in the study.

Study subjects are expected to participate for approximately 1 year following surgical placement of the TIES® Port. Participation will involve a screening period, surgical implantation of the device (inpatient), and scheduled follow-up assessments out to 1 year post-implant.

The study is expected to open to enrollment in the UK in early 2018 and recruit patients for approximately 12 months.

Lay summary of study results:
As the clinical investigation was terminated prematurely, 28 of the 200 participants initially planned were enrolled. The feedback collected from the 28 patients and investigators was very valuable and helped OstomyCure to quickly upgrade the implant port to TIES IV and start to plan for the next clinical study. The data compiled is limited, and none of the intended statistical analyses could be performed, either for the primary endpoint or the secondary. Therefore, the collected data was summarized and analyzed only through descriptive analysis. Information on the primary performance variable, absence of leakage when using the TIES Lid, was available from eight participants who used the TIES Lid for continence control at 24 weeks. For 72 consecutive hours, before the time point of 24 weeks, subjects recorded in a diary if there was visible leakage associated with the use of the lid. In two subjects, the implant was dry, and there were no signs of visible leakage. Six subjects experienced leakage or staining on clothes. Reasons for not using the lid for continence control were problems with the implant, difficulties using the lid, or partial use of the lid.
In the early phase of the investigation, 5 study subjects experienced problems with ingrowth of the implant. The data from these subjects were reviewed, and the cause of the problem likely occurred in study subjects with Crohn's disease. As a result, the study plan was updated with a change in patient selection criteria, and a potential study subject diagnosed with Crohn's disease was no longer eligible.
For subjects who completed the study and had a successful implantation of the device, there was a trend towards improved quality of life. With the limited number of subjects included in the study, and few completed questionnaires particularly towards the later stages of the study, it was difficult to draw any general conclusions. There were trends of improvement, with higher percentages of subjects with question options linked to “no problems” at the later visits, compared to “moderate problems” at baseline. The few respondents mean that results should be analyzed with caution.
Questionnaires had low numbers of respondents, particularly towards the latest visits. The analysis did, however, show improvements over time. The trends all point in the same direction, with improved stoma-related quality of life. One important issue to consider in relation to the above is the dropouts. Subjects remaining in the study are those most satisfied with the treatment, and those for whom it did not work have dropped out at an earlier stage, meaning the results may be biased towards improvement.
When assessing the determination of the tissue ingrowth between the skin and the device, and the mucosa and the device, one-third of the study subjects had at 8 weeks a complete tissue ingrowth. The clinical feedback was related to granulation growth between the port and skin, small areas of missing ingrowth at the top of the port, and not fully fixated flange to the subcutaneous tissue.
From a safety perspective, 11 device deficiencies were reported. Sixty-two device-related adverse effects were reported in 17 subjects. In nine study subjects, 23 serious adverse events were reported. Of the 23 serious events, 19 were classified as related to the product or procedure, i.e., serious adverse device effects. One serious adverse event was reported as unanticipated as the study subject developed extensive skin breakdown around the implant, which was later diagnosed as pyoderma gangrenosum, a skin disease linked to active Mb Crohn. One study subject died; this event was not related to the investigational medical device or procedure.
Overall, the study served its case from a development aspect, and the development of TIES IV would not have been possible without the C03 study. The decision to terminate the C03 study was a very wise decision for OstomyCure and future patients.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
18/YH/0021
Date of REC Opinion
17 Apr 2018
REC opinion
Further Information Favourable Opinion

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w30bob
Jul 16, 2025 3:37 am

Yikes! I sure hope they have better luck with the .4 version than they did with the .3 version! The elimination of Crohn's patients sure cuts the numbers down on those who would use such a device. There's roughly 7 million people worldwide with Crohn's, and of those, about 10-15% will end up with an ileostomy. So TIES just lost 700,000 potential customers. I bet the Sales Team isn't very happy right about now!

But if they never tried and failed.........they'd never succeed! Best of luck to the TIES folks!!

;O)

Gray Logo for MeetAnOstoMate

Eagles2023

Yeah wow, this site helped so much, I mean really who do you know with this infliction? No one, felt so alone and disgusted by myself every turn.
But it ended up being so damn strengthening, I got fucking moving, really only another choice.
That's
Honesty
Truth
I was damaged by a procedure and ended waking with this, I understand all of you.. perhaps you had to have it, I get it.. doesn't matter either way.
Just wanted to share that

Axl
Jul 16, 2025 6:15 am

Well ...... It's encouraging to know that there are people trying to make improvements for ostomates, never say never.

SusanT
Jul 16, 2025 6:28 pm

It looks like the elimination of Crohn's patients is a key safety improvement. I'm sorry they had to learn this the hard way, but it is the nature of research.

I'm happy to see them trying to improve the quality of life for those with ostomies. Even if this innovation won't work for everyone, the next one might.

rlevineia
Jul 20, 2025 4:24 pm

Axl, love your photo. I was at Mayo, down to 107 lbs and dying. The RN asked how I keep positive and humorous. I told her I laugh at death and stuck my tongue out!


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My Ostomy Journey: LeeAnne | Hollister

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Lollidolly
Jul 23, 2025 12:35 am

Wow, thanks for sharing! Sorry to hear your experience was traumatic. I admire your courage to be in the trail and propel innovation forward through participation.

Axl
Jul 23, 2025 5:51 am

If you didn't laugh, you'd cry...

Love your work 🤪