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OpenTrials
Completed

NCT Number: NCT01702662

Photopill Treatment in Healthy Volunteers

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Unpublished study (Melzer, Ben-Yehuda et al.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

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Key information

Conditions

Ulcerated Mucosa of Colon

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Academic Medical Center Amsterdam, department of Gastroenterology

Amsterdam, North Holland, 1105 AZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photopill treatment

Device

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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Acronym: Photopill

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 8, 2012
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.