None listed
Conditions
Interventions
Medical Device : 1. Intervention Description
The medical devices for clinical trials below are applied for 4 weeks.
- Model name:BAMK-M100 (D)
- Pressure Intensity (fixed): Control group step 1 / Stud
Sponsors
BMS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria (Inclusion Criteria) 1) Adult men and women aged 19 to 80 years old. 2) Patients with chronic functional constipation diagnosed according to the ROME III criteria below There should be no dilute stool or diarrhea without laxative use, and it should be inappropriate for the diagnostic criteria for irritable bowel syndrome, symptoms are older than at least 6 months, and chronic functional constipation is diagnosed in the last 3 months. (1) When defecating, the excessive force cycle is at least once out of 4, but the severity is less than 3 points or 4 points on a 5-point scale. (2) At least once out of four hard stools. (3) Incomplete bowel movements at least once out of four times. (4) When defecating, the anus is closed at least once out of four times. (5) Additional treatment is required to help defecation, such as using a finger or pressing the lower abdomen, at least once out of four times. (6) Defecating less than 3 times a week. 3) Those who complete spontaneous bowel movement (CSBMs) are less than 5 times during the introduction period of 2 weeks* *The criteria for selection shall be evaluated at the time of visit 2 after completing the introduction period of 2 weeks. 4) Those who have an abdominal circumference of 60 cm or more and 110 cm or less, and have no difficulty using medical devices for this clinical trial. 5) After listening the detailed explanation of this clinical trial and fully understanding it, a person who voluntarily decided to participate and agreed in writing to comply with precautions.
Exclusion criteria
Exclusion criteria: Exclusion criteria. 1) Medical history and past history. (1) Those who have confirmed abnormalities such as stenosis, malignant tumors, structural problems, defecation disorders* (pelvic obstruction, rectum, perineal descending syndrome, incomplete rectal escape, convulsive pelvic syndrome, etc.) within 2 years of colonoscopic or radiologic evaluation. defecation disorder is defined as a state in which there is no abnormality in the colon itself, and bowel relaxation is not properly performed without the influence of other systemic diseases, and on the contrary, fecal discharge is not performed smoothly by repeating contraction. If the tester is a patient suspected of defecation disorder according to the examination, accompanying comprehensive symptoms, and defecation condition, the patient who is diagnosed with defecation disorder and rectal sphincter pressure should be excluded. (2) Patients with gastrointestinal surgical history or cholecystectomy except appendectomy and inguinal hernia reparing surgery. (3) A person with a history of peritonitis. (4) Acute cardiovascular disease. (5) Inflammatory bowel disease. (6) Implants in the abdominal cavity (catheter, drug pump, etc.) (7) Acute severe respiratory syndrome. (8) A person who has suffered from or is currently suffering from mental illness that significantly affects this clinical trial. (9) A person suffering from a recent abdominal scar, abdominal wound or irritable, inflammatory skin disease that can make abdominal massage uncomfortable using this medical device. (10) Endocrine diseases [Uncontrolled diabetes (fasting blood sugar>200 mg/dL factor), hypothyroidism, hyperparathyroidism, etc.), inflammatory gastrointestinal diseases (ischemic colitis, inflammatory bowel disease, tuberculosis colitis, intestinal sinusitis, rectal dislocation, rectal palace hernia, etc.), neurological diseases (paralysis, etc.). (11) A person who meets irritable bowel syndrome according to the ROME III criteria. Patients with repetitive abdominal pain or abdominal discomfort for more than three days per month on average over the past three months and two or more of the following three symptoms are diagnosed as irritable bowel syndrome. - Abdominal pain or abdominal discomfort is associated with defecation. - The number of defecations changes in relation to abdominal pain or abdominal discomfort. - The shape (hardening) of the stool changes in connection with abdominal pain or abdominal discomfort. *The criteria for exclusion shall be evaluated at the time of visit to Pre-screening. (12) Those who fall under warning symptoms and signs (occurrence of new symptoms related to constipation such as abdominal pain and vomiting, anemia, rectal bleeding, positive fecal occlusion test, weight loss, etc.) Depending on the examination, the accompanying comprehensive symptoms, and bowel movements, we intend to conduct a fecal occlusion test under the medical judgment of the tester. 2) Prohibited concomittent drugs and therapy. (1) If it is not possible to discontinue medicines that affect gastrointestinal exercise, painkillers or antihistamines that can cause secondary constipation, including medications for constipation, during the clinical trial period. (2) Similar therapy to this medical device, such as warm acupressure and massage, is prohibited in the abdomen and waist. 3) Pregnant women (HCG test is performed only for infertile women) 4) Contraception. A person wh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate to spontaneous complete defecation (CSBMs) of the treatment device compared to the introductory phase after 4 weeks of use of the medical device BAMK-M100 (D) | — |
Secondary
| Measure | Time frame |
|---|---|
| After using the medical device BAMK-M100 (D) for 2 weeks and 4 weeks, the amount of change in the number of spontaneous complete defecation (CSBMs) of the treatment device compared to the introduction period;After using the medical device BAMK-M100 (D) for 4 weeks, the amount of change and rate of change in colon transit time (CTT) at 4 weeks compared to baseline.;After using the medical device BAMK-M100 (D) for 4 weeks, the amount of change and rate of change in the evaluation score of the Bristol fecal morphology scale (BSFS) at 4 weeks compared to the baseline;After using the medical device BAMK-M100 (D) for 4 weeks, the evaluation score change amount and rate of change in the patient evaluation questionnaire (PAC-QOL) for constipation quality of life at 4 weeks compared to baseline.;After 4 weeks of use of the medical device BAMK-M100 (D), the rate of change and change in the evaluation score of the 4 weeks constipation symptom questionnaire (excessive force period, residual defecation, anal obstruction, abdominal pain and discomfort, resin manipulation) compared to the baseline. | — |
Countries
Korea, Republic of
Contacts
Public ContactSungwon Yoon
BMS
Outcome results
None listed