Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy
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|ClinicalTrials.gov Identifier: NCT03416023|
Recruitment Status : Unknown
Verified January 2018 by Ostomycure AB.
Recruitment status was: Not yet recruiting
First Posted : January 30, 2018
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ileostomy - Stoma||Device: TIES® (Transcutaneous Implant Evacuation System)||Not Applicable|
This is a multicentre, 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 anaesthesia 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 that require a permanent ileostomy, including patients with ulcerative colitis, familial adenomatous polyposis coli or other diseases such as Crohn´s disease.
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 (in-patient) and scheduled follow-up assessments out to 1 year post implant.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective single-arm multicentre open clinical study|
|Masking:||None (Open Label)|
|Official Title:||Prospective Multicentre Open Clinical Study to Assess the Safety Performance and Durability of the TIES® Transcutaneous Titanium Implant in Patients Requiring a Permanent Ileostomy|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||June 2020|
- Device: TIES® (Transcutaneous Implant Evacuation System)
Transcutaneous Implant Evacuation System
- Patient reported visual assessment [ Time Frame: 24 weeks after implantation of the TIES® Port ]
Visible leakage or fecal staining of clothing recorded on the 3-day diary Performance evaluation applies only among subjects with the TIES® Port in situ. Among subjects with the TIES® Port in situ, performance will be assessed according to (a) the proportion of subjects who use the TIES® Lid for continence control; (b) the proportion of subjects experiencing visible leakages around the implant; and (c) subject´s assessment on the ease of use of the TIES® Solution.
The success criterion at 24 weeks requires at least 70% of subjects with the TIES® Port in situ having no visible leakage or staining of clothing adjacent to the implant between consecutive episodes of using the lid for continence control. Spillage that might occur at opening of the lid is not regarded as leakage.
- Patient reported visual assessment [ Time Frame: 16, 36 and 52 weeks ]Absence of visible leakage or fecal staining of clothing
- Patient diary_use of device [ Time Frame: 16, 24, 36 and 52 weeks after implantation ]Use of TIES® Lid for continence control
- VAS_usability assessment [ Time Frame: 16, 24, 36 and 52 weeks after implantation ]Ease of use of the TIES® Lid using a visual analog scale
- Patient reported preference [ Time Frame: 52 weeks after implantation ]Subject´s preference for the TIES® solution or typical stoma bags
- Device durability assessment [ Time Frame: 8,16, 24, 36 and 52 weeks ]Evaluated by the cumulative proportion of subjects with the TIES® Port in situ
- Treatment emergent adverse events [ Time Frame: Procedure to 52 weeks ]Defined as events with onset during or after the implantation procedure.
- Peristomal skin lesions [ Time Frame: Procedure to 52 weeks ]Evaluated using a validated 5-point scale by assessing signs of erythema, erosion, or papular lesions. The classification of Borglund et al will be used to assess severity of the skin lesions the site. The scale combines erythematous and pseudoverrucous skin lesions assessments. Ranging from no signs (E0/P0) to severe erythematous-erosive skin lesions (E++/P0), to severe pseudoverrucous skin lesions (E0/P++).
- Device-related adverse events [ Time Frame: Procedure to 52 weeks ]
- Device incidents [ Time Frame: Procedure to 52 weeks ]Proportion of implanted subjects with device incidents including; displacement, device revision and device replacement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416023
|Study Director:||Maria Klockare||OstomyCure AS|