Feasibility and efficacy study of a novel device designed to manage fecal incontinence in hospitalized bed-ridden patients.

Consure Medical Pvt Ltd0 个研究点目标入组 10 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patients in neurology and critical care ward that require nursing care for the management of fecal incontinence due to a central neurogenic condition. The volunteers should meet all of the following criteria:
•Patients must be between 18 â?? 75 years of age (Both sexes).
•Fecal incontinence must be caused due to an intracranial or spinal disorder.
•Patient is confirmed to have more than 2 stool/bowel episodes in the last 24 hours.
•Patient has achieved hemodynamic stability.
•Patient or a legal representative of the patient gives written consent for the study.

•Following patients will be not be included in this feasibility study:
•Fecal incontinence caused due to local causes, i.e. any trauma, disease or condition of the muscular apparatus of the ano-rectal region.
•Patients with significant hemorrhoids, growth, ulcers, malignancy, fissure, stricture and local pathology as observed during protoscopic examination. Short-listed patients with external or internal hemorrhoids that are classified as Grade III or lower can be enrolled in the study.
•Patients on oral anti-coagulation.
•Patients that have planned MRI examination over the duration of the study.
•Patients with recent history of colo-rectal surgeries or therapeutic procedures.
•Patients with or having suspicion of ulcerative colitis, Crohnâ??s disease or rectal ulcers.
•Patients suspected to have intestinal tuberculosis.
•Patients on inotropic drugs.
•Patients with confirmed pregnancy or suspected to be pregnant.
•Unwilling patients.
•Enrolled in another clinical study.

发起方

Consure Medical Pvt Ltd