Prospective, monocentric observational study on the clinical use and patient satisfaction of pfmmedical implantable vascular access ports
Organizational Data
- DRKS-ID:
- DRKS00026150
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2022-06-22
- Last update in DRKS:
- 2023-01-09
- Registration type:
- Retrospective
Acronym/abbreviation of the study
PMCF study pfmmedical Ports
URL of the study
No Entry
Brief summary in lay language
The aim of this observational study is to collect follow-up data on implantable ports in the course of post market surveillance for a period of up to six months. The focus is on patient satisfaction and the safety of the implantable ports during and after implantation.
Brief summary in scientific language
Prospective, monocentric, non-randomised, observational post-market clinical follow-up study in Germany to obtain post-market information on the pfmmedical ports with a follow-up (FU) of six months. The focus is on patient reported satisfaction, clinical application, and complication rates.
Health condition or problem studied
- ICD-10-GM (translation):
- Z95.81
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Patients with a medical indication for port implantation
Endpoints
- Primary outcome:
- The study hypothesis is that the patients’ satisfaction after the study intervention is not worse than the satisfaction identified in the current literature. Satisfaction is determined using the patient questionnaire (six months after implantation).
- Secondary outcome:
- none
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsklinikum Heidelberg Portzentrum Heidelberg
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2022-04-13
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 150
- Final Sample Size:
- 150
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- • Age: ≥ 18 years • Medical indication for port catheter implantation. • The patient is mentally able to understand the nature, aims and possible consequences of the PMCF study. • Patient information has been provided and written consent exists.
Exclusion Criteria
• Contraindications according to the manufacturer´s instructions for use (IFU). • The patient is institutionalised by court or official order (MPDG §27). • Patient participates in another operative clinical investigation if it relates to the area of port devices and/or influences the primary endpoint of the PMCF study. • Patients who currently already have a port implanted.
Addresses
Primary Sponsor
- Address:
- pfm medical agWankelstr. 6050996 KölnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.pfmmedical.com
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- pfm medical agKai BraunstefferWankelstraße 6050996 KölnGermany
- Telephone:
- +49 (2236) 9641 226
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.pfmmedical.com
Contact for Public Queries
- Address:
- pfm medical agKai BraunstefferWankelstraße 6050996 KölnGermany
- Telephone:
- +49 (2236) 9641 226
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.pfmmedical.com
Principal Investigator
- Address:
- pfm medical agKai BraunstefferWankelstraße 6050996 KölnGermany
- Telephone:
- +49 (2236) 9641 226
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.pfmmedical.com
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- pfm medical agWankelstr. 6050996 KölnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.pfmmedical.com
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-338220
- Fax:
- +49-6221-3382222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-02-03
- Ethics committee number:
- S-080/2022
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-03-02
Further identification numbers
- Other WHO Primary Registry or Data Provider ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publications/study results:
- No Entry
- Date of the first journal publication of results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry