Photopill Treatment in Healthy Volunteers

Ulcerated Mucosa of Colon Clinical Trial

— Photopill  

Official title:

The Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Healthy Volunteers, a Phase 1 Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702662
• Other study ID #: METC2012_150, ABR: 40642
• Status: Completed
• Phase: Phase 1
• First received: October 3, 2012
• Last updated: December 10, 2012
• Start date: August 2012
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

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Unpublished study (Melzer, Ben-Yehuda et al.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ulcerated Mucosa of Colon

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center Amsterdam, department of Gastroenterology	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability		During Study period: day 0-14	Yes