darmen van gezonde proefpersonen, uiteindelijk doel is darmonstekingen te behandelen Inflammatory Bowel Disease Ulcerative Colitis
Conditions
Interventions
After the rectum of the patient is cleaned with a Saline enema, the Photopill
suppository capsule, mounted on a flexible rectal tube, will be inserted to the
rectum till 10 cm. Finally the capsule w
Sponsors
Photopill Medical Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male or female subject between 18 and 65 years of age Subjects who are generally healthy Signed informed consent.
Exclusion criteria
Exclusion criteria: Subjects with any known GI related symptoms complaints or GI diseases Subjects with cancer or other life threatening diseases or conditions Subjects with cardiovascular or pulmonary diseases Pregnant women Subjects who underwent any colon surgery Morbid Obesity (BMI > 40) Drug abuse or alcoholism Bed-ridden Subject Participation in current clinical study or clinical study within 30 days prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Safety evaluation of the device as determined by the number and severity of Adverse Events in comparison to the baseline condition (Day 0 day 14, and unscheduled visits] * Comparison between baseline sigmoidoscopy assessments of mucosal appearance of the rectal mucosa, and the follow up assessments of the treated area (Day 0, Day 14). | — |
Countries
Netherlands
Outcome results
None listed