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Trial Outcomes & Findings for Preliminary Evaluation of CASTLE Barrier Prototype UK (NCT NCT01530087)

NCT ID: NCT01530087

Last Updated: 2016-03-22

Results Overview

mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

1 - 30 days

Results posted on

2016-03-22

Participant Flow

Participant milestones

Participant milestones
Measure
Subjects With Ileostomy or Colostomy
CASTLE Barrier ostomy device CASTLE barrier: Prototype barrier to be used in place of current two piece device
Overall Study
STARTED
3
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Subjects With Ileostomy or Colostomy
CASTLE Barrier ostomy device CASTLE barrier: Prototype barrier to be used in place of current two piece device
Overall Study
Physician Decision
2

Baseline Characteristics

Preliminary Evaluation of CASTLE Barrier Prototype UK

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Subjects With Ileostomy or Colostomy
n=3 Participants
CASTLE Barrier ostomy device CASTLE barrier: Prototype barrier to be used in place of current two piece device
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=99 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
Sex: Female, Male
Female
1 Participants
n=99 Participants
Sex: Female, Male
Male
2 Participants
n=99 Participants
Region of Enrollment
United Kingdom
3 participants
n=99 Participants

PRIMARY outcome

Timeframe: 1 - 30 days

Population: Study was stopped due to inability to inability to enroll. No data are available for any outcome measures.

mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: Study was stopped ; no data are available

wear time leakage barrier erosion

Outcome measures

Outcome data not reported

Adverse Events

Subjects With Ileostomy or Colostomy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director, Global Clinical Affairs

Hollister Incorporated

Phone: 847.918.3467

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER