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Photopill Treatment in Healthy Volunteers (Photopill)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01702662
First Posted: October 8, 2012
Last Update Posted: December 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanke Brandse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  Purpose

Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in chemotherapy/radiotherapy oral mucositis.

Unpublished study (Melzer, Ben-Yehuda et al.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.


Condition Intervention Phase
Ulcerated Mucosa of Colon Device: Photopill treatment Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Healthy Volunteers, a Phase 1 Trial

Further study details as provided by Hanke Brandse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability [ Time Frame: During Study period: day 0-14 ]

Enrollment: 4
Study Start Date: August 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Photopill treatment
Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times
Device: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 patient.
  • Any rectal therapy.
  • Participation in current clinical study or clinical study within 30 days prior to the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702662


Locations
Netherlands
Academic Medical Center Amsterdam, department of Gastroenterology
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: Geert D'Haens, Prof.dr Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Responsible Party: Hanke Brandse, MD, Phd student, executive investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01702662     History of Changes
Other Study ID Numbers: METC2012_150, ABR: 40642
First Submitted: October 3, 2012
First Posted: October 8, 2012
Last Update Posted: December 11, 2012
Last Verified: December 2012