None listed
Conditions
Interventions
Medical Device : Model : BAMK-M100
The air cell is installed in the inner space of the curved frame and receives air from the pump through supply lines.
The device manipulates the patient’s abdominal
Sponsors
BMS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) age 20–80 years, 2) body mass index 18–40 kg/m2, 3) constipation symptom profile according to the April 2016 Rome IV guidelines, and 4) agreement to participate in this study. CC was defined as constipation with long-term symptom duration (onset = 6 months previously and currently symptomatic for =3 months) and the presence of more than two self-reported symptom clusters (hard stools, straining, sensation of incomplete evacuation, sensation of anorectal obstruction, need for manual maneuvers to facilitate >25% defecation, and fewer than three spontaneous bowel movements per week).
Exclusion criteria
Exclusion criteria: 1) diagnosis by abnormal colonoscopy or abdominal imaging findings within 2 years; 2) constipation related to a previous surgery or other organic disorder, including Parkinson’s disease and paraplegic disorders (stroke, spinal disorders, multiple sclerosis, and hypothyroidism,); 3) history of open abdominal surgery or peritonitis; 4) history of gastric or small bowel surgery; 5) history of gall bladder surgery; 6) cardiovascular, pulmonary, or other endocrinological disorder that might affect study enrollment; and 7) pregnancy or breastfeeding status.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colon Transit Time | — |
Countries
Korea, Republic of
Contacts
Public ContactSungwon Yoon
BMS
Outcome results
None listed