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Point-of-care Anorectal Testing to Predict Outcomes With Biofeedback Therapy: Clinical Trial

NCT04159350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2022-01-19

No results posted yet for this study

Summary

To prospectively evaluate the clinical utility of baseline anorectal function testing using a point-of-care device in predicting response of chronically constipated patients to physical therapy biofeedback training.

Conditions

Interventions

DEVICE

Rectal Expulsion Device (RED) - Feasibility

After a complete physical exam at bedside including a digital rectal exam, the patient is turned on their side and RED is gently inserted into the rectum. The patient is then given one minute to expel RED while remaining on their side. If the patient is unable to pass RED, the patient transfers to a commode and attempts to expel the device. If the device is not expelled, the device can be safely removed at bedside and the patient diagnosed with a biofeedback-responsive evacuation disorder. The RED device is manufactured by Rose Medical (Grand Rapids, MI) under GMP conditions and final assembly is performed by In2Being (Saline, MI). The device contains accepted technologies that are already in use of humans, namely biomedical grade materials.

DEVICE

Rectal Expulsion Device (RED) - Validation

After a complete physical exam at bedside including a digital rectal exam, the patient is turned on their LEFT side and RED is gently inserted into the rectum. The patient then attempts to expel RED while remaining on their side. If the patient is unable to pass RED, the patient transfers to a commode and attempts to expel the device. If the device is not expelled, the device can be safely removed at bedside and the patient diagnosed with a biofeedback-responsive evacuation disorder. The RED device is manufactured by Rose Medical (Grand Rapids, MI) under GMP conditions and final assembly is performed by In2Being (Saline, MI). The device contains accepted technologies that are already in use of humans, namely biomedical grade materials.

Sponsors & Collaborators

  • American Gastroenterological Association

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Eric D. Shah, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2021-09-13
Completion
2021-09-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04159350 on ClinicalTrials.gov