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Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis (Photopill)

Primary Purpose

Ulcerative Colitis, Proctitis

Status
Completed
Phase
Phase 2
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 Ulcerative Colitis focused on measuring Ulcerative Colitis, Ulcerative Proctitis, Low Level Light Therapy, Safety, Efficacy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with Ulcerative Proctitis (Mayo grade 1/2)

Exclusion Criteria:

  • Symptomatic hemorrhoids
  • Pregnant or lactating females
  • Patients that have used any experimental treatment within 8 weeks prior to Day 0
  • Patient that have used any biologics therapies or immunomodulation agents and/or steroids 4 weeks prior to Day 0
  • Rectal therapy 2 weeks prior to Day 0

Sites / Locations

  • Academic Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Photopill treatment

Arm Description

Outcomes

Primary Outcome Measures

Adverse events
Any adverse events reported by subjects

Secondary Outcome Measures

Inflammatory markers
serum CRP, serum Hb/Ht, fecal Calprotectin
Clinical Questionnaires
Simple Clinical Colitis Activity Index Partial Mayo score
Mucosal appearance at sigmoidoscopy
endoscopic disease activity Mayo score and possible damage by device

Full Information

First Posted
April 18, 2013
Last Updated
June 22, 2015
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Photopill Medical Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01837615
Brief Title
Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis
Acronym
Photopill
Official Title
Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular. Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and the Photopill capsule was developed for this purpose. An open-label, interventional, clinical trial was designed for assessment of the safety and feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative Proctitis. Primary endpoints being: safety reflected by the number and severity of adverse events and mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition. Furthermore clinical and biochemical parameters are monitored during the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Proctitis
Keywords
Ulcerative Colitis, Ulcerative Proctitis, Low Level Light Therapy, Safety, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Photopill treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Photopill treatment
Other Intervention Name(s)
Photopill
Primary Outcome Measure Information:
Title
Adverse events
Description
Any adverse events reported by subjects
Time Frame
day 0-42
Secondary Outcome Measure Information:
Title
Inflammatory markers
Description
serum CRP, serum Hb/Ht, fecal Calprotectin
Time Frame
day 0,14,28,42
Title
Clinical Questionnaires
Description
Simple Clinical Colitis Activity Index Partial Mayo score
Time Frame
day 0,14,28,42
Title
Mucosal appearance at sigmoidoscopy
Description
endoscopic disease activity Mayo score and possible damage by device
Time Frame
week 0,14,28.42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Ulcerative Proctitis (Mayo grade 1/2) Exclusion Criteria: Symptomatic hemorrhoids Pregnant or lactating females Patients that have used any experimental treatment within 8 weeks prior to Day 0 Patient that have used any biologics therapies or immunomodulation agents and/or steroids 4 weeks prior to Day 0 Rectal therapy 2 weeks prior to Day 0
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert R D'Haens, MD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
State/Province
North Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis

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