Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a prospective, open-label, single-arm study, to evaluate the ease of use, tolerability, efficacy and safety of the Vibrant Capsule administered in the home environment.
One arm will be assessed: Vibrant Capsule administered twice a week.
Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 6 weeks.
During the 2 weeks of baseline, patients will be asked to refrain from taking any medication or supplement to relieve their constipation.
After 14 days the patients will return and eligibility will be re-assessed. Patients will be instructed to complete a simple patient eDiary each day throughout the duration of the study. After 3 weeks of treatment, the patient will attend for evaluation and to receive new capsules. A final visit will take place at the end of the 6 week treatment period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibrating Capsule | Other | Patients will receive vibrating capsule for 6 weeks of treatment (2 capsules per week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrating capsule | Device | Patients will receive vibrating capsule for 6 weeks of treatment (2 capsules per week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous Bowel Movements success rate | 8 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of complicated/obstructive diverticular disease
History of intestinal or colonic obstruction, or suspected intestinal obstruction.
History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission)
History of gastroparesis
Use of any of the following medications:
Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease.
Presence of cardiac pacemaker or gastric electrical stimulator.
History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.
Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinically significant rectocele, history of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect transit
History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia
Chronic use of non-steroidal anti-inflammatory drugs: chronic use is defined as taking full dose non-steroidal anti-inflammatory drugs more than three times a week for at least six months. Patients on cardiac doses of aspirin may be enrolled in the study
Patients with pelvic floor dysfunction/defecatory disorder, based on patient history
Participation in another clinical study within one month prior to screening.
Women who are pregnant or lactating
Use of any medication for constipation relief during the study, except as rescue medication, as indicated by study rules
Inability to use an electronic daily Diary (on a computer, phone application, tablet or other electronic device) to report bowel movements, symptoms and medication usage
Any other condition which in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ashok Tuteja, MD | University of Utah Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah HealthCare | Salt Lake City | Utah | 84132 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided