Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462124
Status:
COMPLETED
Last Update Posted:
2019-08-08
First Post:
2007-04-16
Brief Title:
Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
Sponsor:
BioProtect
Organization:
BioProtect
Study Overview
Official Title:
One-arm Multi-center Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Goal The studys primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure in prostate cancer subjects undergoing routine XRT treatment Safety of the BioProtect device will be assessed by reporting adverse events
Secondary Goal The studys secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum
Secondary Goal The studys secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum
Detailed Description:
Primary Endpoint Parameters
The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure
1 Serious Adverse Events related to the BioProtect balloon andor implantation procedure Serious adverse event are defined as adverse requiring operation andor associated with prolongation of hospital stay Serious Adverse Events will be documented in Serious Adverse Event Form
2 Adverse Events related to the BioProtect balloon andor implantation procedure Adverse Events will be documented in Adverse Event Form
3 Subjective discomfort related to the balloon and implantation procedure will be assessed by pain analogue scale
Secondary Endpoint Parameters
To assess the efficacy of BioProtect biodegradable balloon implant Efficacy will be measured in terms of
1 Increased distance between anterior rectal wall and prostate post implantation as showed by CT until last radiation treatment
2 Noticeable reduction of isodose level to the rectum post implantation as compared to pre-implantation isodose to the rectum by XRT treatment planning software
Other Measured Observations
1 Balloon non-displacement during treatment phase as shown by CT
2 Balloon remaining inflated during treatment phase as shown by CT
3 Operator satisfaction from BioProtect balloon implantation procedure
The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure
1 Serious Adverse Events related to the BioProtect balloon andor implantation procedure Serious adverse event are defined as adverse requiring operation andor associated with prolongation of hospital stay Serious Adverse Events will be documented in Serious Adverse Event Form
2 Adverse Events related to the BioProtect balloon andor implantation procedure Adverse Events will be documented in Adverse Event Form
3 Subjective discomfort related to the balloon and implantation procedure will be assessed by pain analogue scale
Secondary Endpoint Parameters
To assess the efficacy of BioProtect biodegradable balloon implant Efficacy will be measured in terms of
1 Increased distance between anterior rectal wall and prostate post implantation as showed by CT until last radiation treatment
2 Noticeable reduction of isodose level to the rectum post implantation as compared to pre-implantation isodose to the rectum by XRT treatment planning software
Other Measured Observations
1 Balloon non-displacement during treatment phase as shown by CT
2 Balloon remaining inflated during treatment phase as shown by CT
3 Operator satisfaction from BioProtect balloon implantation procedure
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