Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
4 participants
INTERVENTIONAL
2012-08-31
2012-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule treatment in mice showed a significant beneficial effect on the endoscopic severity of DSS-induced colitis in mice.
Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill treatment in healthy volunteers.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Photopill treatment
Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times
Photopill treatment
2 courses of 5 Photopill treatments within 14 days. In each treatment, 3cm of rectal tissue will be exposed, 2 minutes per cm, to low level light therapy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Photopill treatment
2 courses of 5 Photopill treatments within 14 days. In each treatment, 3cm of rectal tissue will be exposed, 2 minutes per cm, to low level light therapy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Signed informed consent.
Exclusion Criteria
* 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 patient.
* Any rectal therapy.
* Participation in current clinical study or clinical study within 30 days prior to the study.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hanke Brandse
MD, Phd student, executive investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Geert D'Haens, Prof.dr
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Academic Medical Center Amsterdam, department of Gastroenterology
Amsterdam, North Holland, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
METC2012_150, ABR: 40642
Identifier Type: -
Identifier Source: org_study_id