Ileostomy - Stoma
Conditions
Keywords
Implant, continence control, titanium
Brief summary
Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.
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.
Interventions
DEVICETIES® (Transcutaneous Implant Evacuation System)
Transcutaneous Implant Evacuation System
Sponsors
Devicia AB (now part of Veranex)
Ostomycure AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective single-arm multicentre open clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Visible Leakage or Fecal Staining of Clothing at 24 Weeks | 24 weeks after implantation of the TIES® Port | Absence of visible leakage or fecal staining of clothing at 24 weeks after implantation of the TIES® Port. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Visible Leakage or Fecal Staining of Clothing 36 Weeks | 36 weeks | Absence of visible leakage or fecal staining of clothing at 36 weeks assessed in a diary |
| Absence of Visible Leakage or Fecal Staining of Clothing at 52 Weeks | 52 weeks | Absence of visible leakage or fecal staining of clothing at 52 weeks assessed in a diary |
| Proportion of Implanted Subjects Using the TIES Lid at 16 Weeks | 16 weeks | Proportion of implanted subjects using the TIES Lid for continence control at 16 weeks |
| Proportion of Implanted Subjects Using the TIES Lid at 24 Weeks | 24 weeks | Proportion of implanted subjects using the TIES Lid for continence control at 24 weeks |
| Proportion of Implanted Subjects Using the TIES Lid at 36 Weeks | 36 weeks | Proportion of implanted subjects using the TIES Lid for continence control at 36 weeks |
| Absence of Visible Leakage or Fecal Staining of Clothing at 16 Weeks | 16 weeks | Absence of visible leakage or fecal staining of clothing at 16 weeks assessed in a diary |
| Subject's Preferences Regarding Maintaining Body Hygiene | 52 weeks | Number of subjects who found it easier using the TIES® Lid than using stoma bags for periodic emptying of waste |
| Subject's Preferences Regarding Daily Activities | 52 weeks | Number of subjects who found it easier using the TIES® Lid than using stoma bags for periodic emptying of waste |
| Subject's Preferences: Being Worried About Odor From Stoma | 52 weeks | Number of subjects who were less worried when using the TIES® Lid than when using stoma bags for periodic emptying of waste |
| Subject's Preferences: Being Worried About Leakage From Stoma | 52 weeks | Number of subjects who were less worried when using the TIES® Lid than when using stoma bags for periodic emptying of waste |
| Subject's Preferences: Recommending the TIES Solution | 52 weeks | Number of subjects who would recommend the TIES solution to friends or family who need to undergo ileostomy |
| Proportion of Implanted Subjects Using the TIES Lid at 52 Weeks | 52 weeks | Proportion of implanted subjects using the TIES Lid for continence control at 52 weeks |
Countries
Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Exclusion criteria failure | 1 |
| Overall Study | Explanted | 7 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Single | — |
|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 12.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Europe | 28 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 28 |
| other Total, other adverse events | 19 / 28 |
| serious Total, serious adverse events | 9 / 28 |
Outcome results
Primary
Absence of Visible Leakage or Fecal Staining of Clothing at 24 Weeks
Absence of visible leakage or fecal staining of clothing at 24 weeks after implantation of the TIES® Port.
Time frame: 24 weeks after implantation of the TIES® Port
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Absence of Visible Leakage or Fecal Staining of Clothing at 24 Weeks | 2 Participants |
Secondary
Absence of Visible Leakage or Fecal Staining of Clothing 36 Weeks
Absence of visible leakage or fecal staining of clothing at 36 weeks assessed in a diary
Time frame: 36 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Absence of Visible Leakage or Fecal Staining of Clothing 36 Weeks | 2 Participants |
Secondary
Absence of Visible Leakage or Fecal Staining of Clothing at 16 Weeks
Absence of visible leakage or fecal staining of clothing at 16 weeks assessed in a diary
Time frame: 16 weeks
Population: At 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single | Absence of Visible Leakage or Fecal Staining of Clothing at 16 Weeks | 3 participants |
Secondary
Absence of Visible Leakage or Fecal Staining of Clothing at 52 Weeks
Absence of visible leakage or fecal staining of clothing at 52 weeks assessed in a diary
Time frame: 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Absence of Visible Leakage or Fecal Staining of Clothing at 52 Weeks | 1 Participants |
Secondary
Proportion of Implanted Subjects Using the TIES Lid at 16 Weeks
Proportion of implanted subjects using the TIES Lid for continence control at 16 weeks
Time frame: 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Proportion of Implanted Subjects Using the TIES Lid at 16 Weeks | 10 Participants |
Secondary
Proportion of Implanted Subjects Using the TIES Lid at 24 Weeks
Proportion of implanted subjects using the TIES Lid for continence control at 24 weeks
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Proportion of Implanted Subjects Using the TIES Lid at 24 Weeks | 8 Participants |
Secondary
Proportion of Implanted Subjects Using the TIES Lid at 36 Weeks
Proportion of implanted subjects using the TIES Lid for continence control at 36 weeks
Time frame: 36 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Proportion of Implanted Subjects Using the TIES Lid at 36 Weeks | 5 Participants |
Secondary
Proportion of Implanted Subjects Using the TIES Lid at 52 Weeks
Proportion of implanted subjects using the TIES Lid for continence control at 52 weeks
Time frame: 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Proportion of Implanted Subjects Using the TIES Lid at 52 Weeks | 1 Participants |
Secondary
Subject's Preferences: Being Worried About Leakage From Stoma
Number of subjects who were less worried when using the TIES® Lid than when using stoma bags for periodic emptying of waste
Time frame: 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Subject's Preferences: Being Worried About Leakage From Stoma | 1 Participants |
Secondary
Subject's Preferences: Being Worried About Odor From Stoma
Number of subjects who were less worried when using the TIES® Lid than when using stoma bags for periodic emptying of waste
Time frame: 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Subject's Preferences: Being Worried About Odor From Stoma | 1 Participants |
Secondary
Subject's Preferences: Recommending the TIES Solution
Number of subjects who would recommend the TIES solution to friends or family who need to undergo ileostomy
Time frame: 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Subject's Preferences: Recommending the TIES Solution | 1 Participants |
Secondary
Subject's Preferences Regarding Daily Activities
Number of subjects who found it easier using the TIES® Lid than using stoma bags for periodic emptying of waste
Time frame: 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Subject's Preferences Regarding Daily Activities | 1 Participants |
Secondary
Subject's Preferences Regarding Maintaining Body Hygiene
Number of subjects who found it easier using the TIES® Lid than using stoma bags for periodic emptying of waste
Time frame: 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Subject's Preferences Regarding Maintaining Body Hygiene | 1 Participants |