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Synthetic simulator could sharpen Surgeons' skills for rare newborn surgery

NCT ID NCT04114279

Knowledge-focused Sponsor: Boston Children's Hospital 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This trial evaluates a totally synthetic, high-fidelity simulator designed to train surgeons in laparoscopic repair of duodenal atresia, a birth defect where the small intestine is blocked. Surgeons with varying experience—from senior residents to attending pediatric surgeons—will practice on the simulator and be scored on their performance, speed, and the quality of the repair they create. The goal is to see if the simulator can reliably tell apart novice, intermediate, and expert surgeons, and to gather feedback on its realism and teaching value. If successful, it could provide a safe, reusable training tool for a rare but delicate procedure.

What this could mean

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

What this could lead to
If validated, this simulator could become a standard training tool for surgeons, improving skills and patient outcomes without using live animals or cadavers.
What could go wrong
The simulator may not fully replicate real surgery, and its teaching value depends on how well it distinguishes skill levels—results may not generalize to all training programs.

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.

Expected to start

Apr 2020

An estimate. Start dates often move.

Finished

Apr 2020

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

25 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * surgical resident with at least 3 years of training * surgical critical care fellow * pediatric surgery fellow * pediatric surgery attending Exclusion Criteria: * surgery trainee with less than 3 years of training * non-surgeon

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Conditions

The condition(s) this trial relates to.

duodenal atresia

As listed by the trial registrant

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

Duodenal atresia

Contacts and locations

Locations

  • Boston Childrens Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.