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New spray device could replace needles for throat numbing during endoscopy

NCT ID NCT07563062

Symptom relief Sponsor: Zagazig University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new device that numbs the throat and esophagus (OPETA) against standard IV sedation with propofol and ketamine for upper GI endoscopy. 60 adults were enrolled to see which method causes less discomfort and has fewer side effects. The goal is to find a safer, more comfortable option for patients.

What this could mean

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

Active substance
Propofol and Ketamine mixture (Ketofol)
What this could lead to
If successful, this could offer a safer, needle-free alternative to IV sedation for upper GI endoscopy, reducing risks like breathing problems.
What could go wrong
This is a small, completed trial with only 60 participants. The new device may not be as effective or comfortable as IV sedation for 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

60 people

The number who actually took part.

Started

Jan 2023

Finished

Jun 2023

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

21 to 64 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: * Both sexes. * Patients aged between 21-64 years old undergoing elective upper GI endoscopy after taking informed consent. * ASA class II /III * BMI \< 30kg/m2 Exclusion Criteria: * Hypersensitivity to drugs included in the study. * Difficult airway or known airway problems. * Active bleeding from esophageal varices. * Emergency procedure * Low base line oxygen saturation \< 92% at room air. * Cases expected to need general anesthesia for the procedure as judged by endoscopist.

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As listed by the trial registrant

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

Intravenous sedation Topical anesthesia Upper gastrointestinal endoscopy

Contacts and locations

Locations

  • Zagazig university hospitals

    Zagazig, Sharqia Province, 44111, Egypt

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