Carcinoma of Head and NeckPhase 1NCT01007240
Antibacterial Properties of Silicon Incorporated With Quaternary Ammonium Polyethylenimine Nanoparticles
A Phase 1 study testing polyethylenimine (PEI) nanoparticles. in people with Carcinoma of Head and Neck, run by Hadassah Medical Organization.
Trial summary
The aim of this study is to evaluate the antibacterial activity of crosslinked quaternary ammonium polyethylenimine (PEI) nanoparticles incorporated at 1-2% w/w in a commercial soft liner material when compared to the commercial soft liner material. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carcinoma of Head and Neck
- What is being tested?
- polyethylenimine (PEI) nanoparticles.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients post maxillectomy, who are using obturators
Who cannot join
- patients who are not using obturators
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study of the Antibacterial Properties of the Nano Particles Which Incorporated With the Soft Liner Silicone - in Obturators
The aim of this study is to evaluate the antibacterial activity of crosslinked quaternary ammonium polyethylenimine (PEI) nanoparticles incorporated at 1-2% w/w in a commercial soft liner material when compared to the commercial soft liner material.
The investigators' results in vitro showed a significant delay in bacterial growth.
Therefore, the investigators assume to have the same delay in vivo- on patients.
- Conditions
- Carcinoma of Head and Neck
- Being tested
- polyethylenimine (PEI) nanoparticles.
- Keywords
- head and neck carcinoma, obturators, maxillectomy, soft liner, nano particles, antibacterial properties, patients post maxillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylenimine (PEI) nanoparticles.Device
| Study group | Role | What they receive |
|---|---|---|
| soft liner with nano particles | Experimental | the obturators of this patients will be relined with soft liner, with incorporated nano particles. after a week, the soft liner will be taken off, and will be checked for bacterial adhesion. Receives: Device: polyethylenimine (PEI) nanoparticles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial growth
Measured: a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionMay 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- anat b sharon, DMD, MSc, Principal investigator, lecturer, department of maxillofacial rehabilitation, hadassah medical organiztion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007240
- Sponsor's protocol ID
- siliconnanoHMO-CTIL
- Status last verified
- Nov 2009
- First submitted
- 2 Nov 2009
- Last updated
- 4 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Antibacterial Properties of the Nano Particles Which Incorporated With the Soft Liner Silicone - in Obturators
- ClinicalTrials.gov ID
- NCT01007240
- Acronym / sponsor ID
- siliconnanoHMO-CTIL
- Conditions
- Carcinoma of Head and Neck
- Keywords
- head and neck carcinoma, obturators, maxillectomy, soft liner, nano particles, antibacterial properties, patients post maxillectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the antibacterial activity of crosslinked quaternary ammonium polyethylenimine (PEI) nanoparticles incorporated at 1-2% w/w in a commercial soft liner material when compared to the commercial soft liner material.
The investigators' results in vitro showed a significant delay in bacterial growth.
Therefore, the investigators assume to have the same delay in vivo- on patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| soft liner with nano particles | Experimental | Device: polyethylenimine (PEI) nanoparticles.the obturators of this patients will be relined with soft liner, with incorporated nano particles. after a week, the soft liner will be taken off, and will be checked for bacterial adhesion. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients post maxillectomy, who are using obturators
Key exclusion criteria (1 listed)
- patients who are not using obturators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyethylenimine (PEI) nanoparticles. | Device | soft liner with nano particles |
Primary outcome
bacterial growth
Time frame: a week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2009.
Related trials for Carcinoma of Head and Neck
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
anat b sharon, DMD, MSc principal investigator
lecturer, department of maxillofacial rehabilitation, hadassah medical organiztion
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing polyethylenimine (PEI) nanoparticles. in people with Carcinoma of Head and Neck, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact anat b sharon, Msc, DMD (972-54-5255659, anatsharon@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacterial growth (time frame: a week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2009.