Ignite Creation Date:
2024-05-05 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00708942
Status:
TERMINATED
Last Update Posted:
2013-04-24
First Post:
2008-07-01
Brief Title:
Hexaminolevulinate HAL Photodynamic Therapy PDT of Cervical Intraepithelial Neoplasia CIN Grade 1
Sponsor:
Photocure
Organization:
Photocure
Study Overview
Official Title:
A Randomized Phase II Study of Hexaminolevulinate HAL Photodynamic Therapy PDT in Patients With Low-grade Cervical Intraepithelial Neoplasia CIN1
Status:
TERMINATED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment study stopped with only 13 of 70 patients included in second part of the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions dysplasia in women
Detailed Description:
Low-grade cervical intraepithelial neoplasia CIN1 is caused by persistent HPV infection and may worse case develop into cancer In most cases both the virus infection and lesions CIN1 regress spontaneously but must be followed up with gynecological examinations to ensure normalization If further persistent disease and worsening to precancerous lesions CIN2-3 the usual treatment is surgery where one removes the tissue in the cervix where the CIN lesions are
In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate HAL photodynamic therapy PDT HAL PDT is the combination of a medication and a specific type of light to activate the drug HAL PDT selectively removes CIN lesions while preserving normal tissue thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects
In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate HAL photodynamic therapy PDT HAL PDT is the combination of a medication and a specific type of light to activate the drug HAL PDT selectively removes CIN lesions while preserving normal tissue thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None