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| Name | Class |
|---|---|
| Photopill Medical Ltd | UNKNOWN |
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Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular. Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and the Photopill capsule was developed for this purpose.
An open-label, interventional, clinical trial was designed for assessment of the safety and feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative Proctitis.
Primary endpoints being: safety reflected by the number and severity of adverse events and mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition.
Furthermore clinical and biochemical parameters are monitored during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photopill treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photopill treatment | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Any adverse events reported by subjects | day 0-42 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers | serum CRP, serum Hb/Ht, fecal Calprotectin | day 0,14,28,42 |
| Clinical Questionnaires | Simple Clinical Colitis Activity Index Partial Mayo score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geert R D'Haens, MD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | North Holland | 1105 AZ | Netherlands |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D011349 | Proctitis |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| day 0,14,28,42 |
| Mucosal appearance at sigmoidoscopy | endoscopic disease activity Mayo score and possible damage by device | week 0,14,28.42 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |