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Objectives: To assess the safety, efficacy, and performance of a novel colostomy device compared to a traditional pouching system in patients with colostomy.
Methods: This Phase II, 142-day, 4-stage, open-label, non-randomized, multicenter study enrolled patients with end colostomies for ≥3 months, currently wearing a traditional pouching system. During novel device-wear, patients recorded safety outcomes (condition of surrounding skin if skin barrier wafer was changed; color, moisture, physical condition of the stoma; and gastrointestinal symptoms) in daily diaries.
Results: Twenty-six patients entered the study (mean age 55.77 years; 15 female, 11 male). Twenty-one patients completed the study; 2 withdrew due to leakage, 2 withdrew consent, 1 discontinued before novel device wear. During the 21-day usual product wear period, one patient reported 2 adverse events (AEs), (AE rate 0.003/patient day;0.09/patient month); during the 14-day period before novel device-wear, 5 patients reported AEs (AE rate 0.018/patient day;0.54/patient month), one serious; during the 107-day novel device wear period 15 patients reported AEs (AE rate 0.013/patient day;0.39/patient month), three serious and considered not related to treatment. The novel device was worn for 97% of study days; mean daily wear time was 6.21 hours. Main reason for device removal was “time to change”/”study visit” (64%). Investigator ratings of stoma color and moisture remained within normal range throughout the study. During novel device-wearing stage, patients had no unusual gastrointestinal symptoms on 99.7% of days, and no odor was noted for 80% of days. Eighty percent of patients reported stoma noise was less than usual. Mean number of leaks per patient month were 1.2 (traditional) and 4.2 (novel). Microbiology and vascularity profiles did not reveal concerns. Approximately 2/3 of patients preferred the novel device.
Conclusions: This study demonstrated safety and efficacy of the novel device when used for 8 hours per day in colostomy patients.
Methods: This Phase II, 142-day, 4-stage, open-label, non-randomized, multicenter study enrolled patients with end colostomies for ≥3 months, currently wearing a traditional pouching system. During novel device-wear, patients recorded safety outcomes (condition of surrounding skin if skin barrier wafer was changed; color, moisture, physical condition of the stoma; and gastrointestinal symptoms) in daily diaries.
Results: Twenty-six patients entered the study (mean age 55.77 years; 15 female, 11 male). Twenty-one patients completed the study; 2 withdrew due to leakage, 2 withdrew consent, 1 discontinued before novel device wear. During the 21-day usual product wear period, one patient reported 2 adverse events (AEs), (AE rate 0.003/patient day;0.09/patient month); during the 14-day period before novel device-wear, 5 patients reported AEs (AE rate 0.018/patient day;0.54/patient month), one serious; during the 107-day novel device wear period 15 patients reported AEs (AE rate 0.013/patient day;0.39/patient month), three serious and considered not related to treatment. The novel device was worn for 97% of study days; mean daily wear time was 6.21 hours. Main reason for device removal was “time to change”/”study visit” (64%). Investigator ratings of stoma color and moisture remained within normal range throughout the study. During novel device-wearing stage, patients had no unusual gastrointestinal symptoms on 99.7% of days, and no odor was noted for 80% of days. Eighty percent of patients reported stoma noise was less than usual. Mean number of leaks per patient month were 1.2 (traditional) and 4.2 (novel). Microbiology and vascularity profiles did not reveal concerns. Approximately 2/3 of patients preferred the novel device.
Conclusions: This study demonstrated safety and efficacy of the novel device when used for 8 hours per day in colostomy patients.