Photopill Treatment in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanke Brandse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01702662
First received: October 3, 2012
Last updated: December 10, 2012
Last verified: December 2012
  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Unpublished study (Melzer, Ben-Yehuda et al.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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 3, 2012
Last Updated: December 10, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Ulcer
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014