New laryngeal mask could make surgery safer and more comfortable
NCT ID NCT07177586
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a new-generation GMA laryngeal mask with a conventional inflatable mask in patients undergoing elective surgery under general anesthesia. The goal is to see which device is safer, easier to use, and more comfortable for patients. About 1,384 participants will be enrolled across multiple centers, and researchers will assess how well the mask seals and stays in place.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GMA-Tulip Laryngeal Mask Airway (device)
- What this could lead to
- If successful, this could provide evidence for a safer, more comfortable airway device during surgery, potentially reducing complications.
- What could go wrong
- This is a device comparison study, not a treatment trial. Results may not show significant advantage, and findings may not apply to all patient types or settings.
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
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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
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About 1,384 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Inclusion Criteria 1. Age 18-75 years; 2. ASA physical status I-II; 3. Strict compliance with ASA fasting guidelines; 4. Normal airway anatomy; 5. Voluntary participation with signed informed consent. * Exclusion Criteria: 1. Pre-existing aspiration risk or gastrointestinal disorders; 2. Oropharyngeal/laryngeal abnormalities; 3. Anticipated difficult airway (≥1 of the following): BMI \>30 kg/m² Mouth opening \<3 cm Mallampati class III-IV Restricted neck mobility 4. Contraindications to LMA use; 5. Communication or cognitive impairments; 6. Other exclusions at investigator's discretion
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First affiliated Hospital, School of Medicine, Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310000, China