Radiofrequency ResectionNCT03175770
Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery
An observational study of Radiofrequency Resection, run by Technical University of Munich at 1 site in Germany.
Trial summary
In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiofrequency Resection
- What is being tested?
- transoral radiofrequency Resection in Oropharyngeal Tumor Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2015to 15 Jun 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 years or older, benign or malign tumor of the oropharynx. the resection must be done transorally
Who may be able to join
- 18 years and older benign or malign tumor of the oropharynx tumor must be resectable transorally
Who cannot join
- Prior radiotherapy or chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.
Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.
Read the detailed description
In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.
Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.
- Conditions
- Radiofrequency Resection
- Being tested
- transoral radiofrequency Resection in Oropharyngeal Tumor Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transoral radiofrequency Resection in Oropharyngeal Tumor SurgeryProcedure or surgery
Patient of 18 years and older with benign or malign tumor in the oropharynx. The resection is done transorally by radiofrequency
| Study group | Role | What they receive |
|---|---|---|
| Patients with benign or malign tumor in the oropharynx | Patient of 18 years and older with benign or malign tumor in the oropharynx. The resection is done transorally by radiofrequency Receives: Procedure: transoral radiofrequency Resection in Oropharyngeal Tumor Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
total blood loss,
assessing the blood loss by measuring blood in the suction
Measured: intraoperative
tissuesticking
tissuesticking by physician global assessment scale from 1 - 6
Measured: intraoperative
coagulation
coagulation by physician global assessment scale from 1 - 6,
Measured: intraoperative
Duration of Operation
measuring Duration of Operation in minutes
Measured: intraoperative
Secondary outcomes (6)
Zone of coagulation
Zone of coagulation to assess the tissue damage by radiofrequency by a scale 1 - 6,
Measured: within one month after the operation
postoperative parameters
woundhealing by Parameters normal, delayed, infection;
Measured: within one month after the operations
postoperative pain
postoperative pain by visual analog scale from 0 -10,
Measured: within one month after the operations
accuracy of section
accuracy of section assessed by a scale from 1 - 6
Measured: within one month after the operations
status of resection
assessment of status of resection by assessing the margins of resection for Tumor scale from 1 - 6,
Measured: within one month after the operations
postoperative dysfunctions by descriptive name of scale
postoperative dysfunctions by descriptive scale from 1 -10
Measured: within one month after the operations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Jan 2015
- Primary completion1 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiofrequency ResectionStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clemens Heiser, MD, Principal investigator, department for ENT, Klinikum Rechts der Isar der Technischen Universität München, Ismaninger Straße 22, 81675 München, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175770
- Sponsor's protocol ID
- 381/14
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery
- ClinicalTrials.gov ID
- NCT03175770
- Acronym / sponsor ID
- 381/14
- Conditions
- Radiofrequency Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 5 Jun 2017 (actual)
- 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.
In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.
Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.
Detailed description
In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.
Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with benign or malign tumor in the oropharynx | – | Procedure: transoral radiofrequency Resection in Oropharyngeal Tumor SurgeryPatient of 18 years and older with benign or malign tumor in the oropharynx. The resection is done transorally by radiofrequency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years or older, benign or malign tumor of the oropharynx. the resection must be done transorally
Key inclusion criteria (1 listed)
- 18 years and older benign or malign tumor of the oropharynx tumor must be resectable transorally
Key exclusion criteria (1 listed)
- Prior radiotherapy or chemotherapy
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 |
|---|---|---|
| transoral radiofrequency Resection in Oropharyngeal Tumor SurgeryPatient of 18 years and older with benign or malign tumor in the oropharynx. The resection is done transorally by radiofrequency | Procedure or surgery | Patients with benign or malign tumor in the oropharynx |
Primary outcome
total blood loss,
Time frame: intraoperative
assessing the blood loss by measuring blood in the suction
tissuesticking
Time frame: intraoperative
tissuesticking by physician global assessment scale from 1 - 6
coagulation
Time frame: intraoperative
coagulation by physician global assessment scale from 1 - 6,
Duration of Operation
Time frame: intraoperative
measuring Duration of Operation in minutes
6 secondary outcomes
Zone of coagulation
Time frame: within one month after the operation
postoperative parameters
Time frame: within one month after the operations
postoperative pain
Time frame: within one month after the operations
accuracy of section
Time frame: within one month after the operations
status of resection
Time frame: within one month after the operations
postoperative dysfunctions by descriptive name of scale
Time frame: within one month after the operations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
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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.
Clemens Heiser, MD principal investigator
department for ENT, Klinikum Rechts der Isar der Technischen Universität München, Ismaninger Straße 22, 81675 München, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiofrequency Resection, run by Technical University of Munich at 1 site in Germany.
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: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total blood loss, (time frame: intraoperative). The study lists 4 primary outcomes in all. 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 25 Mar 2020.