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New surgical wrap aims to cut palate injuries in half

NCT ID NCT07552545

Symptom relief Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study compares two ways to lift the soft palate during throat surgery to see which causes fewer injuries. About 138 people aged 2 to 70 who need this type of surgery will be randomly assigned to either the standard double-strap method or a new full-wrap method. The goal is to find out if the full-wrap reduces damage to the soft palate and helps it heal faster.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
full-wrap suspension device
What this could lead to
If it works, this could offer a safer way to hold the soft palate during surgery, reducing injury and speeding up healing.
What could go wrong
This is a small, early-stage trial (138 people) that hasn't started yet. The new method may not be better than the standard one, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 138 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntarily sign the informed consent form; for patients aged \<18 years, the informed consent form must be signed by their legal guardian. * Age between 2 and 70 years (inclusive), male or female. * Patients requiring transoral surgery of the nose, pharynx, parapharyngeal space, or skull base, in which intraoperative soft palate suspension is needed. * Intact soft palate mucosa with no ulcers, scars, or other lesions before surgery. Exclusion Criteria: * Congenital cleft palate or submucous cleft palate. * Patients with limited cervical spine mobility, micrognathia, or other conditions affecting surgical exposure. * Pregnant or breastfeeding women. * Presence of markedly abnormal laboratory test results, such as significant abnormalities in routine blood tests, blood biochemistry, liver and kidney function, or coagulation function. * Patients with active infection or infectious diseases. * Severe cardiac insufficiency (NYHA class III-IV). * Other conditions deemed unsuitable for surgery after evaluation (e.g., concomitant severe heart, brain, or lung diseases; high anesthetic risk; patients not fit for surgery).

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Conditions

The condition(s) this trial relates to.

adenoid hypertrophy nasopharyngeal disorder nasopharyngeal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenoid hypertrophy Nasopharyngeal diseases Nasopharyngeal tumors Parapharyngeal or skull base lesions Required soft palate suspension Tonsillar hypertrophy

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000, China

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