Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.

Inclusion Criteria:

- Male and female patients, more than 18 years of age incontinent with liquid to
semi-formed stool.

- Non-ambulatory, hospitalized patients.

- History of passage of at least 1 stool in 24 hours.

Exclusion Criteria:

- Patients with suspected or confirmed rectal mucosal impairment or pathology.

- Patients with have undergone descending colon or rectal surgery within the preceding
six months.

- Patients with significant hemorrhoids, growth, fissure, stricture, stenosis or local
pathology (either benign and malignant) as observed during rectal examination.

- Patients suspected to have impacted stool or is suffering from constipation.

- Patients with confirmed pregnancy or suspected to be pregnant.

- Patients that have planned MRI examination over the duration of the study.

- Patients who have suffered recent cardiac arrest within the preceding 3 months.

- Patients enrolled in another clinical study or clinical trial.

- Patients on oral or IV anti-coagulation (e.g., IV heparin drip, acetylsalicylic acid
, Plavix). Subcutaneous heparin or low molecular weight heparin are acceptable).