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Clinical Trials/NCT01702662
NCT01702662CompletedPhase 1

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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 sites in 1 country4 target enrollmentStarted: August 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
4
Locations
2
Primary Endpoint
Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability

Study Overview

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Unpublished study (Melzer, Ben-Yehuda et al.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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Photopill treatment

Experimental

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

Intervention: Photopill treatment (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hanke Brandse

MD, Phd student, executive investigator

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

Study Sites (2)

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