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Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
MedPass International
Sigma3 Services SARL
Information provided by (Responsible Party):
Ostomycure AB

Brief Summary:
Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.

Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Device: TIES® (Transcutaneous Implant Evacuation System) Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective single-arm multicentre open clinical study
Masking: None (Open Label)
Primary Purpose: Treatment
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

Intervention Details:
  • Device: TIES® (Transcutaneous Implant Evacuation System)
    Transcutaneous Implant Evacuation System


Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Patient reported visual assessment [ Time Frame: 16, 36 and 52 weeks ]
    Absence of visible leakage or fecal staining of clothing

  2. Patient diary_use of device [ Time Frame: 16, 24, 36 and 52 weeks after implantation ]
    Use of TIES® Lid for continence control

  3. 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

  4. Patient reported preference [ Time Frame: 52 weeks after implantation ]
    Subject´s preference for the TIES® solution or typical stoma bags

  5. 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

  6. Treatment emergent adverse events [ Time Frame: Procedure to 52 weeks ]
    Defined as events with onset during or after the implantation procedure.

  7. 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++).

  8. Device-related adverse events [ Time Frame: Procedure to 52 weeks ]
  9. Device incidents [ Time Frame: Procedure to 52 weeks ]
    Proportion of implanted subjects with device incidents including; displacement, device revision and device replacement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has ulcerative colitis, familial adenomatous polyposis coli or other diseases such as Crohn´s disease for whom a permanent ileostomy is indicated; or the subject has a medical need for an alternative to an existing conventional end-ileostomy, continent ileostomy or pelvic pouch; and
  • Patient is a male ≥18 years of age or female ≥18 years of age (See exclusion criterion 4 regarding female with childbearing potential); and
  • Signed written informed consent has been obtained prior to any study- related procedure.

Exclusion Criteria:

  • Concurrent gastrointestinal fistula, parastomal or incisional hernia, or a history of recurrent gastrointestinal fistula, recurrent parastomal hernia(s), and/or recurrent incisional hernia(s).
  • Patients with undetermined colitis.
  • An acute episode of Crohn´s disease occurring during the last three months before the operation
  • Females who are of childbearing potential and do not wish to use birth control measures for the duration of the study
  • Patients receiving immunosuppressives, oncologic treatment or anticoagulants.
  • Any clinically significant, abnormal, baseline laboratory result which in the opinion of the surgeon, affects the patient's suitability for the study or puts the patient at risk if he/she undergoes surgery
  • Severe illness which, in the opinion of the surgeon may put the patient at risk when participating in the study or may affect the patient's ability to complete the study visits
  • Condition associated with the risk of poor protocol compliance, e.g. alcoholism and/or drug abuse, dementia, self-destructive personality disorder
  • Subjects with BMI ≤ 17 kg/m2 or BMI ≥ 33 kg/m2
  • Participate in other clinical studies that could interfere with the result in the ongoing study

Information from the National Library of Medicine

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


Sponsors and Collaborators
Ostomycure AB
MedPass International
Sigma3 Services SARL
Investigators
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Study Director: Maria Klockare OstomyCure AS
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Responsible Party: Ostomycure AB
ClinicalTrials.gov Identifier: NCT03416023    
Other Study ID Numbers: TIES® III C03
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently no plan to share IPD but OstomyCure would be open to requests

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ostomycure AB:
Implant
continence control
titanium