The evaluation of the safety and feasibilty of the Photopill capsule treatment in healthy volunteers, a phase 1 trial
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
darmen van gezonde proefpersonen, uiteindelijk doel is darmonstekingen te behandelen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* 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).
Secondary outcome
not applicable
Background summary
Photobiostimulation, or Light therapy utilizes specific non-ionizing,
non-thermal light wavelengths irradiation, by low intensity lasers (LLLT) or
LED's, for the purpose of tissue healing for many skin and mucosal diseases
that involve wounds, ulcers and inflammation.
Phototherapy has a proven positive effect not only on skin diseases, but on
mucosal membrane as well. Such influence is described in several mucosal
conditions and oral chemotherapy-induced mucositis in particular.
IBD is characterized by chronic tissue inflammation, tissue damage and
ulcerations in various extents, and as such show considerable resemblance to
many skin and mucosal conditions that are treated by light.
This observation suggest that photobiostimulation can be effective in treating
inflammatory gastrointestinal (GI) diseases and IBD in particular.
Photopill capsule has been developed specially for the treatment of IBD.
Therefore a phase 1 trial will probably be performed.
Study objective
The evaluation of the safety and feasibilty of the Photopill capsule treatment
in healthy volunteers, a phase 1 trial
Study design
Open-label, interventional, independently controlled, clinical study
Intervention
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 will be activated.
Every 2 minutes, the rectal tube will be pulled out 1 cm distal to the previous
location, and will be held in the new location for 2 minutes. The process will
be repeated until 3cm colon mucosa is covered. 1 Treatmensession will constist
of 5 sequential treatments with a 10 minutes break in between.
In total 2 treatment sessions will take place within 14 days. At day 0 and day
14 a sigmoidoscopy will be performed,
Study burden and risks
The main risk factor of the capsule is thermal damage of the intestinal mucosa
due to light therapy.
This factor was examined during the pre-clinical studies in pigs and found to
be non-significant.
Another side effect may be tissue erosion due to the insertion of the
suppository capsule.
The rectal treatment sessions might be experienced as unpleasant and the same
will possibly account for the repeating sigmoidoscopies.
New Industrial Park, Bldg. 7
Yokneam Illit 20692
IL
New Industrial Park, Bldg. 7
Yokneam Illit 20692
IL
Listed location countries
Age
Inclusion criteria
Male or female subject between 18 and 65 years of age
Subjects who are generally healthy
Signed informed consent.
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40642.018.12 |