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| Name | Class |
|---|---|
| Scripps Clinic | OTHER |
| Augusta University Medical Center | UNKNOWN |
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Constipation affects 12-19% of Americans. Pelvic floor dyssynergia is considered to play an important role in constipation but the underlying mechanisms are not well understood in individual patients. The investigators have developed a novel device named Fecobionics that provide detailed mapping of physiological parameters during defecation. The aim of the study is to use Fecobionics to assess anorectal function in dyssynergia patients and monitor and predict the outcome of the biofeedback therapy.
This study aims to monitor and predict biofeedback therapy based on mechanism-based and highly integrated data using a new medical device. This study is specifically for patients with dyssynergia before, during, and after biofeedback therapy. The balloon-like Fecobionics device (10 cm long and 1 cm in diameter) will be inserted into the participant's rectum and will record data before and during the expulsion of the device. The participant will be asked to do different motions like cough, squeeze, or push during the procedure. The novel data obtained in this study may help the investigators to identify the patients who will benefit or not benefit from biofeedback therapy before the therapy is done. This will determine the effectiveness of treatments for anorectal disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecobionics | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecobionics | Device | Fecobionics is a novel device to be inserted through the anal canal into rectum for studying defecation. Anorectal manometry and balloon expulsion test may be used as reference. Anorectal manometry and balloon expulsive test are standard methods for anorectal functional measurement. |
| Measure | Description | Time Frame |
|---|---|---|
| Expulsion Duration | The time it takes to defecate Fecobionics | 1.5 year |
| Pressure Difference between front and rear ends of Fecobionics | A measure of anal sphincter pressure, the driving rectal pressure, and the difference between these two pressures. This is the key to the determination of defecation phases. | 1.5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Anorectal angle | Anorectal angle is an important parameter for defecation | 1.5 year |
| Mechanical Tension of Fecobionics | To reflect anorectal function, the mechanical tension will be computed. The tension is equal to anorectal radius multiply pressure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hans Gregersen, PhD | Contact | 858-249-7400 | hag@giome.org | |
| Satish Rao, MD, PhD | Contact | 706-7212238 | srao@augusta.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Medical Innovations Institute | Recruiting | San Diego | California | 92121 | United States |
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| ID | Term |
|---|---|
| D001259 | Ataxia |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| 1.5 year |
| Expulsion Velocity | Measured from the time difference between multiple sensor data | 1.5 year |
| Cross-sectional area | Computed by diameter | 1.5 year |
| Digestive Health Center- Augusta University | Recruiting | Augusta | Georgia | 30912 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |