Trial Outcomes & Findings for Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy (NCT NCT03416023)

NCT ID: NCT03416023

Last Updated: 2025-03-11

Results Overview

Absence of visible leakage or fecal staining of clothing at 24 weeks after implantation of the TIES® Port.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: 24 weeks after implantation of the TIES® Port
• Results posted on: 2025-03-11

Participant Flow

Participant milestones

Measure	TIES Implantation TIES® (Transcutaneous Implant Evacuation System) implantation
Overall Study STARTED	28
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	TIES Implantation TIES® (Transcutaneous Implant Evacuation System) implantation
Overall Study Exclusion criteria failure	1
Overall Study Withdrawal by Subject	6
Overall Study Explanted	7
Overall Study Physician Decision	1
Overall Study Lost to Follow-up	1
Overall Study Death	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Single n=28 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Age, Continuous	47 years STANDARD_DEVIATION 12.2 • n=28 Participants
Sex: Female, Male Female	8 Participants n=28 Participants
Sex: Female, Male Male	20 Participants n=28 Participants
Region of Enrollment Europe	28 participants n=28 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Single n=8 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Absence of Visible Leakage or Fecal Staining of Clothing at 24 Weeks	2 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: At 16 weeks

Absence of visible leakage or fecal staining of clothing at 16 weeks assessed in a diary

Outcome measures

Measure	Single n=10 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Absence of Visible Leakage or Fecal Staining of Clothing at 16 Weeks	3 participants

SECONDARY outcome

Timeframe: 36 weeks

Absence of visible leakage or fecal staining of clothing at 36 weeks assessed in a diary

Outcome measures

Measure	Single n=5 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Absence of Visible Leakage or Fecal Staining of Clothing 36 Weeks	2 Participants

SECONDARY outcome

Timeframe: 52 weeks

Absence of visible leakage or fecal staining of clothing at 52 weeks assessed in a diary

Outcome measures

Measure	Single n=1 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Absence of Visible Leakage or Fecal Staining of Clothing at 52 Weeks	1 Participants

SECONDARY outcome

Timeframe: 16 weeks

Proportion of implanted subjects using the TIES Lid for continence control at 16 weeks

Outcome measures

Measure	Single n=19 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Proportion of Implanted Subjects Using the TIES Lid at 16 Weeks	10 Participants

SECONDARY outcome

Timeframe: 24 weeks

Proportion of implanted subjects using the TIES Lid for continence control at 24 weeks

Outcome measures

Measure	Single n=19 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Proportion of Implanted Subjects Using the TIES Lid at 24 Weeks	8 Participants

SECONDARY outcome

Timeframe: 36 weeks

Proportion of implanted subjects using the TIES Lid for continence control at 36 weeks

Outcome measures

Measure	Single n=19 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Proportion of Implanted Subjects Using the TIES Lid at 36 Weeks	5 Participants

SECONDARY outcome

Timeframe: 52 weeks

Proportion of implanted subjects using the TIES Lid for continence control at 52 weeks

Outcome measures

Measure	Single n=19 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Proportion of Implanted Subjects Using the TIES Lid at 52 Weeks	1 Participants

SECONDARY outcome

Timeframe: 52 weeks

Number of subjects who found it easier using the TIES® Lid than using stoma bags for periodic emptying of waste

Outcome measures

Measure	Single n=8 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Subject's Preferences Regarding Maintaining Body Hygiene	1 Participants

SECONDARY outcome

Timeframe: 52 weeks

Number of subjects who found it easier using the TIES® Lid than using stoma bags for periodic emptying of waste

Outcome measures

Measure	Single n=8 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Subject's Preferences Regarding Daily Activities	1 Participants

SECONDARY outcome

Timeframe: 52 weeks

Number of subjects who were less worried when using the TIES® Lid than when using stoma bags for periodic emptying of waste

Outcome measures

Measure	Single n=8 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Subject's Preferences: Being Worried About Odor From Stoma	1 Participants

SECONDARY outcome

Timeframe: 52 weeks

Number of subjects who were less worried when using the TIES® Lid than when using stoma bags for periodic emptying of waste

Outcome measures

Measure	Single n=8 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Subject's Preferences: Being Worried About Leakage From Stoma	1 Participants

SECONDARY outcome

Timeframe: 52 weeks

Number of subjects who would recommend the TIES solution to friends or family who need to undergo ileostomy

Outcome measures

Measure	Single n=8 Participants TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Subject's Preferences: Recommending the TIES Solution	1 Participants

Adverse Events

Single

Serious events: 9 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Measure	Single n=28 participants at risk TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Gastrointestinal disorders Infection, implant site	3.6% 1/28 • Number of events 1 • 2.5 years
Skin and subcutaneous tissue disorders Suspicion of pyoderma gangrenosum	3.6% 1/28 • Number of events 1 • 2.5 years
Gastrointestinal disorders Self-explant of device (device misplacement or displacement)	3.6% 1/28 • Number of events 1 • 2.5 years
Gastrointestinal disorders Ileus	3.6% 1/28 • Number of events 2 • 2.5 years
Gastrointestinal disorders Re-fashioning of ileostomy	3.6% 1/28 • Number of events 1 • 2.5 years
Gastrointestinal disorders Sepsis	3.6% 1/28 • Number of events 1 • 2.5 years
Gastrointestinal disorders Intestinal obstruction	10.7% 3/28 • Number of events 4 • 2.5 years
Gastrointestinal disorders Stenosis, stoma related event	3.6% 1/28 • Number of events 1 • 2.5 years
Skin and subcutaneous tissue disorders Erythema at site	3.6% 1/28 • Number of events 1 • 2.5 years
Gastrointestinal disorders Narrow passage caused by irritated or swollen intestine	7.1% 2/28 • Number of events 3 • 2.5 years
Skin and subcutaneous tissue disorders Pain and redness following bowel resection to device (mucocutaneous separation/ peristomal skin lesi	3.6% 1/28 • Number of events 1 • 2.5 years
Gastrointestinal disorders Infection and dehydration	3.6% 1/28 • Number of events 1 • 2.5 years
Skin and subcutaneous tissue disorders Skin breakdown, pain, swelling	3.6% 1/28 • Number of events 1 • 2.5 years
Gastrointestinal disorders Dehiscence and leaking around the device	3.6% 1/28 • Number of events 1 • 2.5 years
Gastrointestinal disorders Pelvic infection	3.6% 1/28 • Number of events 2 • 2.5 years
Gastrointestinal disorders Incorrect ingrowth	3.6% 1/28 • Number of events 2 • 2.5 years
Cardiac disorders Cardiac arrest	3.6% 1/28 • Number of events 1 • 2.5 years

Other adverse events

Measure	Single n=28 participants at risk TIES® (Transcutaneous Implant Evacuation System): Transcutaneous Implant Evacuation System
Cardiac disorders Cardiac event	3.6% 1/28 • Number of events 2 • 2.5 years
Gastrointestinal disorders Dyspepsia	3.6% 1/28 • Number of events 1 • 2.5 years
Gastrointestinal disorders Gastroenteritis	7.1% 2/28 • Number of events 5 • 2.5 years
Gastrointestinal disorders Granulation	3.6% 1/28 • Number of events 1 • 2.5 years
Blood and lymphatic system disorders Infection, blood	7.1% 2/28 • Number of events 4 • 2.5 years
Gastrointestinal disorders Infection, bowel	7.1% 2/28 • Number of events 3 • 2.5 years
Respiratory, thoracic and mediastinal disorders Infection, pulmonary	7.1% 2/28 • Number of events 2 • 2.5 years
Gastrointestinal disorders Intestinal obstruction	14.3% 4/28 • Number of events 7 • 2.5 years
Gastrointestinal disorders Irritable bowel	14.3% 4/28 • Number of events 9 • 2.5 years
Gastrointestinal disorders Non-optimal ingrowth	14.3% 4/28 • Number of events 4 • 2.5 years
Skin and subcutaneous tissue disorders Skin reaction	39.3% 11/28 • Number of events 16 • 2.5 years

Additional Information

Johan Järte

OstomyCure AS

Phone: +46 706 524 532

Email: jjaerte@ostomycure.com

Results disclosure agreements

• Principal investigator is a sponsor employee Data need to be submitted by the PIs to the sponsor for review and comment at least 60 days prior to submission for publication, public dissemination, or review by a publication committee. All reasonable comments made by the sponsor shall be incorporated into the publication. The sponsor shall be entitled to make a reasoned request that publication be delayed for a period of up to 6 months from the date of first submission to the sponsor.
• Publication restrictions are in place

Restriction type: OTHER