Trial Outcomes & Findings for The Advocate Study (NCT NCT02401412)

Last Updated: 2018-07-11

Results Overview

12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization.

Recruitment status

COMPLETED

Study phase

Target enrollment

170 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Test Ostomy Barrier The test product is a new Hollister ostomy barrier. Test Ostomy Barrier	Control Ostomy Barrier The control product is a currently marketed Hollister ostomy barrier. Control Ostomy Barrier
Overall Study STARTED	89	81
Overall Study Received Study Device	89	80
Overall Study COMPLETED	59	49
Overall Study NOT COMPLETED	30	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Ostomy Barrier The test product is a new Hollister ostomy barrier. Test Ostomy Barrier	Control Ostomy Barrier The control product is a currently marketed Hollister ostomy barrier. Control Ostomy Barrier
Overall Study Lost to Follow-up	1	0
Overall Study Discontinued Intervention	15	21
Overall Study Withdrawal by Subject	4	4
Overall Study Subject withdrawal prior to intervention	0	1
Overall Study Improper Enrollment per In/Ex Criteria	10	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Ostomy Barrier n=79 Participants The test product is a new Hollister ostomy barrier. Test Ostomy Barrier	Control Ostomy Barrier n=74 Participants The control product is a currently marketed Hollister ostomy barrier. Control Ostomy Barrier	Total n=153 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 24.8 • n=79 Participants	57.2 years STANDARD_DEVIATION 15.2 • n=74 Participants	56.3 years STANDARD_DEVIATION 15.3 • n=153 Participants
Sex: Female, Male Female	29 Participants n=79 Participants	31 Participants n=74 Participants	60 Participants n=153 Participants
Sex: Female, Male Male	50 Participants n=79 Participants	43 Participants n=74 Participants	93 Participants n=153 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	15 participants n=79 Participants	12 participants n=74 Participants	27 participants n=153 Participants
Region of Enrollment United States	56 participants n=79 Participants	53 participants n=74 Participants	109 participants n=153 Participants
Region of Enrollment Europe	8 participants n=79 Participants	9 participants n=74 Participants	17 participants n=153 Participants
BMI	24.8 kg/m2 STANDARD_DEVIATION 5.8 • n=79 Participants	26.4 kg/m2 STANDARD_DEVIATION 5.8 • n=74 Participants	25.6 kg/m2 STANDARD_DEVIATION 5.8 • n=153 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The analysis population was defined as a modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such 153 (170-17) subjects were eligible for analysis

Outcome measures

Outcome measures
Measure	Test Ostomy Barrier n=79 Participants The test product is a new Hollister ostomy barrier. Test Ostomy Barrier	Control Ostomy Barrier n=74 Participants The control product is a currently marketed Hollister ostomy barrier. Control Ostomy Barrier
Stoma Related Cost of Care	223.73 USD Interval 210.86 to 236.6	260.19 USD Interval 242.79 to 277.58

SECONDARY outcome

Timeframe: 8 weeks

Observed 8 week Peristomal Skin Complication (PSC) rate. The validated Ostomy Skin Tool DET score was used to describe the status of the peristomal skin. Subjects were deemed to have had a PSC if the DET score was above zero due to anything other than normal postoperative healing and/or scar tissue, or the DET score increased above the normal score obtained at a previous visit.

Outcome measures

Outcome measures
Measure	Test Ostomy Barrier n=79 Participants The test product is a new Hollister ostomy barrier. Test Ostomy Barrier	Control Ostomy Barrier n=74 Participants The control product is a currently marketed Hollister ostomy barrier. Control Ostomy Barrier
Peristomal Skin Complication Rate	32 Participants	41 Participants

Adverse Events

Test Ostomy Barrier

Serious events: 12 serious events

Other events: 6 other events

Deaths: 2 deaths

Control Ostomy Barrier

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test Ostomy Barrier n=79 participants at risk The test product is a new Hollister ostomy barrier. Test Ostomy Barrier	Control Ostomy Barrier n=74 participants at risk The control product is a currently marketed Hollister ostomy barrier. Control Ostomy Barrier
Cardiac disorders Myocardial infarction	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	0.00% 0/74 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Infections and infestations Death due to septic shock	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	0.00% 0/74 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Infections and infestations Pelvic Abscess	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	1.4% 1/74 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Renal and urinary disorders Renal Failure	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	0.00% 0/74 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Gastrointestinal disorders Intestinal Blockage/Illeus	5.1% 4/79 • Number of events 4 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	1.4% 1/74 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Respiratory, thoracic and mediastinal disorders Acute shortness of breath	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	0.00% 0/74 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Renal and urinary disorders Urinary Tract Infection	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	0.00% 0/74 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death due to primary cancer	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	0.00% 0/74 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Gastrointestinal disorders Abdominal Pain	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	0.00% 0/74 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Gastrointestinal disorders Inflamed gall bladder	0.00% 0/79 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	1.4% 1/74 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
General disorders Non-specific Failure to Thrive	0.00% 0/79 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	1.4% 1/74 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Renal and urinary disorders Non-specific Pain	0.00% 0/79 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	1.4% 1/74 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Infections and infestations Cellulitis	0.00% 0/79 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	1.4% 1/74 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects

Other adverse events

Other adverse events
Measure	Test Ostomy Barrier n=79 participants at risk The test product is a new Hollister ostomy barrier. Test Ostomy Barrier	Control Ostomy Barrier n=74 participants at risk The control product is a currently marketed Hollister ostomy barrier. Control Ostomy Barrier
Surgical and medical procedures Elective colonoscopy	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	0.00% 0/74 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Infections and infestations Incisional Abscess	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	0.00% 0/74 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Gastrointestinal disorders Intestinal Blockage/Illeus	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	1.4% 1/74 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Injury, poisoning and procedural complications Stoma abrasion caused by patient	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	0.00% 0/74 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Skin and subcutaneous tissue disorders Skin Rash	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	0.00% 0/74 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Product Issues Ostomy pouching system not secure	1.3% 1/79 • Number of events 1 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	0.00% 0/74 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Skin and subcutaneous tissue disorders Peristomal Skin Complication	0.00% 0/79 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	9.5% 7/74 • Number of events 7 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects
Gastrointestinal disorders Stoma complication	0.00% 0/79 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects	4.1% 3/74 • Number of events 4 • 12 weeks Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product. Adverse Events were reported for the modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such AEs reported for 153 (170-17) subjects

Additional Information

Stacy Haddad, Global Clinical Affairs Director

Hollister Incorporated

Phone: 847-680-2837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60