|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03356119 |
|
Date of registration:
|
20/11/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Pilot Removal of Palpable Subdermal Contraceptive Rod Implants
REVALID02 |
|
Scientific title:
|
A Prospective, Single-centre, Non-comparative Feasibility Investigation to Evaluate Performance and Safety of RemovAid ™ Retrieval Device When Used for Removal of Palpable Subdermal Contraceptive Rod Implants. |
|
Date of first enrolment:
|
December 12, 2017 |
|
Target sample size:
|
19 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT03356119 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Sweden
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Female age 18 or older
- Willing to remove a palpable subdermal Implanon/ Nexplanon CI
- Willing and able to give written informed consent for participation in the
investigation
- Willing to provide follow-up information according to the Clinical Investigators
brochure
Exclusion Criteria:
- Known allergy to local anaesthetic (lidocaine/lignocaine) or disinfectant
(chlorhexidine).
- Active skin lesion over the CI.
- The Investigator considers the subject unlikely to comply with investigational
procedures, restrictions and requirements.
- Any contraindication for removal of the PI, as judged by the Investigator.
- Any disorders or medications that might affect coagulation, as judged by the
Investigator.
- Any conditions suspected to affect healing or increase risk of infection (e.g. keloid
tendency, diabetes or any upper arm dermatological condition that may affect upper arm
healing)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Removal of Contraceptive Implant
|
|
Intervention(s)
|
|
Device: RemovAid device
|
|
Primary Outcome(s)
|
|
Successful removal of implant .
[Time Frame: 15 minutes]
|
|
Secondary Outcome(s)
|
|
Frequency, severity, causality and outcome of adverse events (AEs)
[Time Frame: 1 week]
|
|
Success of fixation of implant
[Time Frame: 5 minutes]
|
|
Technical functionality of device determined by an operators questionnaire
[Time Frame: 5 minutes]
|
|
Duration of procedure
[Time Frame: 25 minutes]
|
|
Operators impression of the device
[Time Frame: 5 minutes]
|
|
Pain during procedure
[Time Frame: 5 minutes]
|
|
Subject satisfaction
[Time Frame: Time Frame: 5 minutes]
|
|
Secondary ID(s)
|
|
REVALID02
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|