Recruiting

Pharyngeal Wall Augmentation

Sponsor:

Vanessa Torrecillas

Code:

NCT07264036

Conditions

Velopharyngeal Insufficiency

Head and Neck Cancer

Survivorship

Dysphagia

Speech Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pharyngeal Wall Augmentation Injection

Study Details

Brief summary:

Some head and neck cancer survivors develop velopharyngeal dysfunction (VPD), a problem with closure between the soft palate and throat that can cause nasal-sounding speech, food or liquid leaking into the nose, difficulty swallowing, and reduced quality of life. This study aims to better understand VPD in this population and to evaluate whether pharyngeal wall augmentation (plumping up the back wall of the throat) can improve speech and swallowing.

Participants will undergo a multidisciplinary assessment including physical examination, flexible nasolaryngoscopy, speech recording and acoustic analysis, nasometry, clinical swallowing evaluation, and fiberoptic endoscopic evaluation of swallowing (FEES).

Aim 1: Determine the prevalence, severity, and functional impact of VPD in head and neck cancer survivors.

Aim 2: Assess the feasibility and usefulness of advanced diagnostic tools for VPD.

The investigators hypothesize that high nasalance scores (>1 SD above normal) will accurately predict VPD with at least 75% positive predictive value and will correlate with worse communication-related quality of life (CPIB).

The investigators also hypothesize that participants with VPD will have more pharyngeal residue or nasal regurgitation on FEES, and that these findings will be associated with lower swallowing-related quality of life (SWAL-QOL).

Aim 3: Evaluate the effectiveness of pharyngeal wall augmentation injections for improving speech intelligibility and swallowing function.

The investigators expect that this treatment will lead to measurable changes in both objective assessments and patient-reported outcomes. The results will help improve diagnosis and management of VPD in head and neck cancer survivors.

Conditions

Velopharyngeal Insufficiency

Head and Neck Cancer

Survivorship

Dysphagia

Speech Disorder

Study ID

NCT07264036

Start date

Mar 24, 2026

Status verified date

Apr, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

English-speaking adults (≥18 years) History of head and neck cancer treated with surgical resection, chemoradiation, or both Presence of perceptual hypernasality on clinical assessment

Exclusion Criteria:

Pre-existing or suspected non-cancer-related causes of velopharyngeal dysfunction Contraindications to pharyngeal wall augmentation Requirement for more intensive active cancer surveillance Planned future surgical or medical treatments to the pharynx that would interfere with participation

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic with Possible Injection Augmentation

All participants will undergo a standardized, multidisciplinary evaluation including physical examination, flexible nasolaryngoscopy, acoustic speech analysis, nasometry, clinical swallowing assessment, and fiberoptic endoscopic evaluation of swallowing (FEES). A subset of participants with confirmed velopharyngeal dysfunction (VPD) who meet clinical criteria may elect to receive a pharyngeal wall augmentation injection as part of standard-of-care treatment. All participants, regardless of whether they receive the injection, will have pre-assessment data collected to evaluate speech intelligibility, nasalance, swallowing function, and patient-reported outcomes. The patients who undergo the pharyngeal augmentation injection will also have post-assessment data collected. No formal comparison between participants who do and do not receive the injection will be performed; all data will be analyzed individually.

Interventions

Pharyngeal Wall Augmentation Injection

Participants with confirmed velopharyngeal dysfunction (VPD) who meet clinical criteria may elect to receive a pharyngeal wall augmentation injection. The procedure involves the submucosal injection of a biocompatible material into the posterior pharyngeal wall to improve velopharyngeal closure during speech and swallowing. Injection volume and technique will be determined by the treating clinician based on individual anatomy and functional assessment. All participants will undergo standardized assessments of speech intelligibility, nasalance, swallowing function, and patient-reported outcomes before and after the procedure.

Timing:

The procedure will occur once at the clinically indicated visit. Post-procedure assessments will be conducted at standardized follow-up intervals to evaluate functional outcomes

Primary outcome measure

  • Feasibility of Nasometry and FEES for Characterizing Velopharyngeal Dysfunction [ Time Frame: Baseline Assessment ]

Central Contacts and Locations

Central contacts

Vanesssa Torrecillas, MD

434-924-2040vge3bm@uvahealth.org

Elena Squire, MPH

434-243-3607EM8KZ@uvahealth.org

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Vanessa Torrecillas, MD

4349242040vge3bm@uvahealth.org

Elena Squire, MPH

434-243-3607EM8KZ@uvahealth.org

Principal Investigator:

Vanessa Torrecillas, MD

More Information

Sponsor

Vanessa Torrecillas

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • velopharyngeal dysfunction
  • hypernasal speech
  • pharyngeal wall augmentation
  • nasometry
  • head and neck cancer
  • survivorship

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanessa Torrecillas on 2026-04-28.