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Photopill Treatment in Healthy Volunteers (Photopill)

Primary Purpose

Ulcerated Mucosa of Colon

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Photopill treatment
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerated Mucosa of Colon

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Academic Medical Center Amsterdam, department of Gastroenterology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Photopill treatment

Arm Description

Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
October 3, 2012
Last Updated
December 10, 2012
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT01702662
Brief Title
Photopill Treatment in Healthy Volunteers
Acronym
Photopill
Official Title
The Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Healthy Volunteers, a Phase 1 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerated Mucosa of Colon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Photopill treatment
Arm Type
Experimental
Arm Description
Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times
Intervention Type
Device
Intervention Name(s)
Photopill treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert D'Haens, Prof.dr
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center Amsterdam, department of Gastroenterology
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands

12. IPD Sharing Statement

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Photopill Treatment in Healthy Volunteers

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