Oral Cavity DiseaseNCT06381505
RetracTOR/ Retractor for Image Guided Trans-Oral Surgery
An observational study of Oral Cavity Disease, run by Ryan J. Halter at 1 site in United States.
Trial summary
This study aims to demonstrate that a polymer retractor functions the same as a standard metal retractor used during endoscopy and throat surgery. The retractor is the device that holds the mouth open so the surgeon can easily access the mouth and throat. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cavity Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Clinical diagnosis or suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring resection.
Who may be able to join
- Clinical diagnosis or suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring resection.
- Undergoing staging endoscopy at DHMC
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years old
- For females of child bearing potential, a negative pregnancy evaluation per standard of care.
Who cannot join
- Prisoners
- Adults with impaired decision-making capacity
- Any condition for which, in the opinion of the investigator, contraindicates study participation.
- Procedures that use high temperature generating devices such as laser
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Joseph Paydarfar, MD, 603-650-8123, joseph.a.paydarfar@hitchcock.org
About this study
Official title: In Vivo Evaluation of a CT-Compatible Retractor for Image Guided Trans-Oral Surgery
This study aims to demonstrate that a polymer retractor functions the same as a standard metal retractor used during endoscopy and throat surgery. The retractor is the device that holds the mouth open so the surgeon can easily access the mouth and throat. For example, this study aims to confirm that the mouth is held open the same amount with a polymer retractor as it is with a metal retractor. Benchtop experiments have demonstrated that the metal and polymer retractor's function the same, and thus this study will use this in patients.
Read the detailed description
This study will include four stages of data collection: 1) Subject history, 2) intraoperative surgical working volume (SWV) assessment with stereoendoscopy and standard-of-care metal retractor, 3) intraoperative surgical working volume assessment with stereoendoscopy and 3D-printed polymer retractor, 4) intraoperative surgical working volume assessment with CT-imaging and 3D-printed polymer retractor.
The investigators will conduct a comparative study examining differences in surgical exposure within the same patient when retraction is enabled through use of standard-of-care metal retractor vs. our 3D printed retractor. Patients to be recruited for the study will include those who present to the Head and Neck Tumor Clinic at Dartmouth-Hitchcock Medical Center (DHMC) with suspicious lesions identified in the oropharynx, hypopharynx or larynx. Currently the clinic sees about 20 patients per month that are scheduled for staging endoscopy in the operating room. Consent will be obtained from all participating subjects prior to participation.
All surgeries will be performed at the Center for Surgical Innovation. Prior to surgery a standard-of-care Feyh-Kastenbauer (FK) or Crowe-Davis (CD) metal retractor will be positioned in the mouth of the patient and stabilized in suspension. A standard-of-care stereo vision endoscope will capture images of the oral cavity so that a 3D volume of the surgical working volume (SWV) can be measured. The time to place the retractor and surgical working volume metrics based on stereovision derived oral-cavity volumes and inter-incisive distance (IID) will be recorded. The FK and/or CD retractor will then be removed and replaced with our custom 3d-printed radiolucent retractor. The time to place this retractor and surgical working volume metrics based on stereovision derived oral-cavity volumes and inter-incisive distance will be recorded. A single CT scan with IV contrast will be obtained with the retractor in place and suspended. The standard surgical procedure will commence following routine methods. Following surgery, a second set of surgical working volume metrics based on stereovision derived oral-cavity volumes and inter-incisive distance will be recorded.
- Conditions
- Oral Cavity Disease
- Keywords
- retractor
- Medical subject headings
- Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| custom device- radiolucent retractor | Custom device-radiolucent retractor used during staging endoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing intraoperative surgical working volume (SWV) of a radiolucent retractor (custom device) as compared to SWV of standard-of-care metal retractors.
Assessment of intraoperative surgical working volume (SWV) during stereoendoscopy using standard-of-care metal retractor as compared to the same assessment parameters using 3D-printed polymer retractor during stereoendoscopy. Assessments will also include intraoperative SWV with CT-imaging taken with 3D-printed polymer retractor.
Measured: 2024-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start25 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity DiseaseStudies of the same condition, open and under way.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ryan J. Halter
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Sponsor-investigator, Ryan J. Halter, Dartmouth-Hitchcock Medical Center
- Investigators
- Ryan J Halter, PhD, Principal investigator, Dartmouth-Hitchcock, Lebanon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381505
- Sponsor's protocol ID
- STUDY02002103
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Evaluation of a CT-Compatible Retractor for Image Guided Trans-Oral Surgery
- ClinicalTrials.gov ID
- NCT06381505
- Acronym / sponsor ID
- STUDY02002103
- Conditions
- Oral Cavity Disease
- Keywords
- retractor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ryan J. HalterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Apr 2024 (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.
This study aims to demonstrate that a polymer retractor functions the same as a standard metal retractor used during endoscopy and throat surgery. The retractor is the device that holds the mouth open so the surgeon can easily access the mouth and throat. For example, this study aims to confirm that the mouth is held open the same amount with a polymer retractor as it is with a metal retractor. Benchtop experiments have demonstrated that the metal and polymer retractor's function the same, and thus this study will use this in patients.
Detailed description
This study will include four stages of data collection: 1) Subject history, 2) intraoperative surgical working volume (SWV) assessment with stereoendoscopy and standard-of-care metal retractor, 3) intraoperative surgical working volume assessment with stereoendoscopy and 3D-printed polymer retractor, 4) intraoperative surgical working volume assessment with CT-imaging and 3D-printed polymer retractor.
The investigators will conduct a comparative study examining differences in surgical exposure within the same patient when retraction is enabled through use of standard-of-care metal retractor vs. our 3D printed retractor. Patients to be recruited for the study will include those who present to the Head and Neck Tumor Clinic at Dartmouth-Hitchcock Medical Center (DHMC) with suspicious lesions identified in the oropharynx, hypopharynx or larynx. Currently the clinic sees about 20 patients per month that are scheduled for staging endoscopy in the operating room. Consent will be obtained from all participating subjects prior to participation.
All surgeries will be performed at the Center for Surgical Innovation. Prior to surgery a standard-of-care Feyh-Kastenbauer (FK) or Crowe-Davis (CD) metal retractor will be positioned in the mouth of the patient and stabilized in suspension. A standard-of-care stereo vision endoscope will capture images of the oral cavity so that a 3D volume of the surgical working volume (SWV) can be measured. The time to place the retractor and surgical working volume metrics based on stereovision derived oral-cavity volumes and inter-incisive distance (IID) will be recorded. The FK and/or CD retractor will then be removed and replaced with our custom 3d-printed radiolucent retractor. The time to place this retractor and surgical working volume metrics based on stereovision derived oral-cavity volumes and inter-incisive distance will be recorded. A single CT scan with IV contrast will be obtained with the retractor in place and suspended. The standard surgical procedure will commence following routine methods. Following surgery, a second set of surgical working volume metrics based on stereovision derived oral-cavity volumes and inter-incisive distance will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| custom device- radiolucent retractor | – | –Custom device-radiolucent retractor used during staging endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical diagnosis or suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring resection.
Key inclusion criteria (5 listed)
- Clinical diagnosis or suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring resection.
- Undergoing staging endoscopy at DHMC
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years old
- For females of child bearing potential, a negative pregnancy evaluation per standard of care.
Key exclusion criteria (5 listed)
- Prisoners
- Adults with impaired decision-making capacity
- Any condition for which, in the opinion of the investigator, contraindicates study participation.
- Procedures that use high temperature generating devices such as laser
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparing intraoperative surgical working volume (SWV) of a radiolucent retractor (custom device) as compared to SWV of standard-of-care metal retractors.
Time frame: 2024-2025
Assessment of intraoperative surgical working volume (SWV) during stereoendoscopy using standard-of-care metal retractor as compared to the same assessment parameters using 3D-printed polymer retractor during stereoendoscopy. Assessments will also include intraoperative SWV with CT-imaging taken with 3D-printed polymer retractor.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Ryan J Halter, PhD principal investigator
Dartmouth-Hitchcock, Lebanon
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 Oral Cavity Disease, run by Ryan J. Halter at 1 site in United States.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan J Halter, PhD (603 646-0773, Ryan.J.Halter@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing intraoperative surgical working volume (SWV) of a radiolucent retractor (custom device) as compared to SWV of standard-of-care metal retractors. (time frame: 2024-2025). 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 7 Apr 2026.