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Trial registered on ANZCTR


Registration number
ACTRN12613000357752
Ethics application status
Approved
Date submitted
27/03/2013
Date registered
4/04/2013
Date last updated
3/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective, multicentre, non randomized clinical study to investigate the safety and performance of the TIES III (Transcutaneous Implant Evacuation System) percutaneous titanium implant in patients undergoing surgery for permanent ileostomy or repair of a pre-existing permanent ileostomy
Scientific title
Prospective, multicentre, non randomized clinical study to investigate the safety and performance of the TIES III (Transcutaneous Implant Evacuation System) percutaneous titanium implant in patients undergoing surgery for permanent ileostomy or repair of a pre-existing permanent ileostomy
Secondary ID [1] 282184 0
NONE
Universal Trial Number (UTN)
Trial acronym
TIES III Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with ulcerative colitis, familial adenomatous polyposis coli, other diseases requiring elective coloproctectomy with a permanent ileostomy 288697 0
Patients with a failing conventional or continent ileostomy 288747 0
Condition category
Condition code
Oral and Gastrointestinal 289046 289046 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Creation of a continent stoma with the TIES-III System in gastroenterological surgery. The system prevents seepage and eliminates the need for wearing an external appliance (e.g. pouch/bag) on the abdomen for collection of faeces or urine.

The duration of the intervention is similar to the duration of intervention for conventional ileostomy. Patients will be followed during 24 months after intervention.
Intervention code [1] 286791 0
Treatment: Devices
Comparator / control treatment
NA- This is a single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289157 0
Grades have been defined to evaluate the performance of the study device.

Leakage is defined as ocular or haptic / tactile detection of at least one drip of waste fluid, alternatively enough of leaking substance to be ocularly or hapticly detected.

The success criterion is defined by a grade 0 to 2 of leakage. If leakage grade is higher than 2 then this will be considered as a failure:
- Grade 0: total absence of leakage
- Grade 1: leakage is observed at 3 hours or more after the last evacuation
- Grade 2: leakage is observed between 2 hours and less than 3 hours after the last evacuation
- Grade 3: leakage is observed between 1 hour and less than 2 hours after the last evacuation
- Grade 4: leakage is observed immediately or less than 1 hour after the last evacuation

To be noted that in certain circumstances or events the device function may be altered. In such a case the use of a poach will be prescribed and success evaluation will be temporary stopped.
Timepoint [1] 289157 0
At 24 months after completion of the procedure
Secondary outcome [1] 301944 0
Evaluation of the absence of infection
Timepoint [1] 301944 0
At 24 months after completion of the procedure
Secondary outcome [2] 302054 0
Evaluation of the tissue adaptation (skin/device) defined at a scale of three levels: healed 360 degrees; partly not attached; not attached (clinically)
Timepoint [2] 302054 0
At 24 months after completion of the procedure
Secondary outcome [3] 302055 0
Evaluation of discomfort/convenience: this will be judged by patients in a questionnaire and will be expressed as a subjective opinion
Timepoint [3] 302055 0
At 24 months after completion of the procedure

Eligibility
Key inclusion criteria
Patient will be included if all of the following criteria are met:
1) Patient has an ulcerative colitis, familial adenomatous polyposis coli or any other diseases requiring elective coloproctectomy with a permanent ileostomy or
Patient is already presenting a failing conventional or continent ileostomy or patient has an indication for permanent ileostomy
2) Patient is not suitable for pelvic pouch surgery
3) Patient is a male or female =18 years of age
4) Signed written informed consent has been obtained prior to any study related procedure
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient will not be included if any one of the following conditions exists:
1) Patient has been diagnosed with or was treated for a Crohn disease
2) Patient presenting a pathology with a long term immunosuppressive treatment (including corticoids)
3) Condition associated with the risk of poor protocol compliance, e.g. alcoholism or drug abuse
4) Participate in other clinical studies that could interfere with the result in the ongoing study
5) Females who are of childbearing potential and not taking adequate contraceptive precautions
6) Patients receiving an immunosuppressing medication or undergoing oncologic treatment
7) Patient with a medical history of fistula

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
No formal hypothesis has been conducted for establishment of the number of subjects to be included in the study, given that no comparison was possible thanks to reported results in previous studies.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
As the CE mark was obtained based on data from the first 5 subjects phase II was no longer planned.
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4954 0
France
State/province [1] 4954 0
Country [2] 20727 0
Czech Republic
State/province [2] 20727 0
Country [3] 20728 0
Norway
State/province [3] 20728 0

Funding & Sponsors
Funding source category [1] 286951 0
Commercial sector/Industry
Name [1] 286951 0
OstomyCure AS
Address [1] 286951 0
Gaustadalleen 21
0349 OSLO, Norway
Country [1] 286951 0
Norway
Primary sponsor type
Commercial sector/Industry
Name
OstomyCure AS
Address
Gaustadalleen 21
0349 OSLO, Norway
Country
Norway
Secondary sponsor category [1] 285737 0
None
Name [1] 285737 0
Address [1] 285737 0
Country [1] 285737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289004 0
Comite de Protection des Personnes (CPP) Ile de France V
Ethics committee address [1] 289004 0
Comite de Protection des Personnes (CPP) Ile de France 5
184, avenue du Faubourg St Antoine
75012 Paris
Ethics committee country [1] 289004 0
France
Date submitted for ethics approval [1] 289004 0
18/12/2012
Approval date [1] 289004 0
05/02/2013
Ethics approval number [1] 289004 0
Ethics committee name [2] 301143 0
Etickà.komise FNKV
Ethics committee address [2] 301143 0
Srobàrova1150/50,
Praha 10. 100 34
Ethics committee country [2] 301143 0
Czech Republic
Date submitted for ethics approval [2] 301143 0
18/11/2013
Approval date [2] 301143 0
15/01/2014
Ethics approval number [2] 301143 0
KH/65/0/2013
Ethics committee name [3] 301144 0
REK sør-øst
Ethics committee address [3] 301144 0
Gullhaugveien 1-3, 0484 Oslo
Ethics committee country [3] 301144 0
Norway
Date submitted for ethics approval [3] 301144 0
24/02/2015
Approval date [3] 301144 0
27/04/2015
Ethics approval number [3] 301144 0
2015/383 REK sør-øst B

Summary
Brief summary
The objective is to evaluate the safety and performance of the TIES system used to secure the evacuation of the ileum content. This device should provide a system with total absence or limited appearance of leakage when the lid is used and between two evacuations of the ileum content.

The study subjects are patients with ulcerative colitis, familial adenomatous polyposis coli, other diseases requiring elective coloproctectomy with a permanent ileostomy, patients with a failing conventional or continent ileostomy
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38750 0
Prof Emmanuel Tiret
Address 38750 0
Hopital Saint Antoine
184, rue du Faubourg Saint Antoine
75012 Paris
Country 38750 0
France
Phone 38750 0
+33 1 49 28 25 63
Fax 38750 0
Email 38750 0
emmanuel.tiret@sat.aphp.fr
Contact person for public queries
Name 38751 0
Dr Benedict Broennimann
Address 38751 0
Gaustadalleen 21
0349 OSLO, Norway
Country 38751 0
Norway
Phone 38751 0
+41 79 301 6272
Fax 38751 0
Email 38751 0
bbroennimann@ostomycure.com
Contact person for scientific queries
Name 38752 0
Dr Benedict Broennimann
Address 38752 0
Gaustadalleen 21
0349 OSLO, Norway
Country 38752 0
Norway
Phone 38752 0
+41 79 301 6272
Fax 38752 0
Email 38752 0
bbroennimann@ostomycure.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary