Ignite Creation Date:
2024-05-06 @ 8:35 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02775058
Status:
UNKNOWN
Last Update Posted:
2016-06-29
First Post:
2016-03-24
Brief Title:
CP009 SYNERGOSS PXX Observational
Sponsor:
Nobil Bio Ricerche srl
Organization:
Nobil Bio Ricerche srl
Study Overview
Official Title:
Clinical Evaluation Protocol Post Market Follow Up Pavia CP009 SYNERGOSS PXX Observational
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
RECRUITING
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:
The device under investigation is SYNERGOSS a CE European Community CE marked device
Synergoss is a granulated bone graft intended for use in dental applications It is composed of a ceramic composite of Hydroxihapatite and Tricalciumphosphate in granules coated with a dedicated collagen coating porcine origin obtained by means of collagen crosslinking on the ceramic granule surface
The purpose of the study is to confirm the foreseen efficacy and tolerability of SYNERGOSS a synthetic dental graft coated with collagen For this observational study we will enroll patients that already received a surgical intervention for sinus augmentation socket preservation by means of SYNERGOSS to maintain and regenerate bone before installation of endosseous titanium implants to support a fixed prosthesis Patients will be enrolled just before they receive the surgery for the installation of endosseous titanium implants about 24 weeks after the first surgery for the implant of SYNERGOSS
The primary hypothesis is to demonstrate that SYNERGOSS consistently obtains the foreseen clinical benefit as declared in the Technical File
The secondary hypothesis is to demonstrate that SYNERGOSS side effects and risks match those declared in the Technical File
The study design is a
National
Monocentric
Prospective the participants are identified and then followed forward in time
Observational participants that have recently received the grafting with SYNERGIES as part of normal and foreseen clinical procedures are enrolled in the study when they receive surgery for titanium implant placement and observed over time with no substantial intervention other than the foreseen clinical treatment
Synergoss is a granulated bone graft intended for use in dental applications It is composed of a ceramic composite of Hydroxihapatite and Tricalciumphosphate in granules coated with a dedicated collagen coating porcine origin obtained by means of collagen crosslinking on the ceramic granule surface
The purpose of the study is to confirm the foreseen efficacy and tolerability of SYNERGOSS a synthetic dental graft coated with collagen For this observational study we will enroll patients that already received a surgical intervention for sinus augmentation socket preservation by means of SYNERGOSS to maintain and regenerate bone before installation of endosseous titanium implants to support a fixed prosthesis Patients will be enrolled just before they receive the surgery for the installation of endosseous titanium implants about 24 weeks after the first surgery for the implant of SYNERGOSS
The primary hypothesis is to demonstrate that SYNERGOSS consistently obtains the foreseen clinical benefit as declared in the Technical File
The secondary hypothesis is to demonstrate that SYNERGOSS side effects and risks match those declared in the Technical File
The study design is a
National
Monocentric
Prospective the participants are identified and then followed forward in time
Observational participants that have recently received the grafting with SYNERGIES as part of normal and foreseen clinical procedures are enrolled in the study when they receive surgery for titanium implant placement and observed over time with no substantial intervention other than the foreseen clinical treatment
Detailed Description:
None
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