Photopill Treatment in Healthy Volunteers | NCT01702662

Studies
Photopill Treatment in Healthy Volunteers

NCT01702662

Sponsor

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

Status

Completed

Last Update Posted

Dec 11, 2012Estimated

Enrollment

4Actual

Phase

Phase 1

Conditions

Ulcerated Mucosa of Colon

Interventions

Photopill treatment

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Oct 3, 2012

First Submission Date that Met QC Criteria

Oct 5, 2012

First Posted Date

Oct 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2012

Last Update Posted Date

Dec 11, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hanke Brandse, MD, Phd student, executive investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Principal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Photopill treatment	Experimental	Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times	Device: Photopill treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Geert D'Haens, Prof.dr	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academic Medical Center Amsterdam, department of Gastroenterology		Amsterdam	North Holland	1105 AZ	Netherlands