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Robot takes the strain out of gallstone surgery

NCT ID NCT07368335

Disease control Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study compares a new robotic-assisted endoscope to the standard method for removing gallstones stuck in the common bile duct. The robot aims to protect doctors from radiation and repetitive strain injuries while keeping the procedure just as effective. About 200 adults with bile duct stones will be randomly assigned to either robotic or conventional ERCP to see if the robot is a safe and reliable option.

What this could mean

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

Active substance
Robotic-assisted ERCP device
What this could lead to
If successful, this robotic system could become a safer alternative for doctors performing ERCP, reducing their radiation exposure and physical strain while maintaining stone removal success.
What could go wrong
This is a non-inferiority trial, meaning it only aims to show the robot is not worse than the standard method. It is still early-stage, and the robot may not improve patient outcomes or could introduce new technical challenges.

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 200 people

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

Started

Dec 2025

Expected to finish

Dec 2026

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

18 to 80 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: 1. Aged 18 to 80 years, inclusive. 2. Diagnosed with common bile duct stones based on symptoms, signs, laboratory tests, and imaging examinations, and deemed suitable by the investigator for endoscopic common bile duct stone removal (lithotomy). 3. Willing to comply with all study procedures; able to understand the study purpose, and voluntarily provide written informed consent. Exclusion Criteria: 1. Severe cardiac, pulmonary, renal, or hepatic insufficiency, or mental disorders. 2. Active viral hepatitis. 3. Upper gastrointestinal stenosis, obstruction, or any condition preventing endoscopic access to the descending duodenum. 4. Known intolerance to anesthetics or hypersensitivity to contrast agents. 5. Non-lithogenic obstructive acute pancreatitis or acute exacerbation of chronic pancreatitis. 6. Pregnant or lactating women. 7. Active peptic ulcer or upper gastrointestinal hemorrhage within one month prior to informed consent. 8. Known severe bleeding tendency (coagulopathy). 9. History of upper gastrointestinal reconstruction surgery resulting in altered anatomy. 10. Previous endoscopic sphincterotomy of the duodenal papilla. 11. Inability to cooperate with ERCP procedures. 12. Participation in a drug clinical trial within the past 3 months, or in another medical device clinical trial (excluding non-interventional studies) within the past month. 13. Any other condition that, in the opinion of the investigator, may render the participant unsuitable for the trial (including but not limited to duodenal mucosal edema, papillary malformation, papillary surface ulcer, papillary fistula, or difficult-to-treat stones).

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Conditions

The condition(s) this trial relates to.

choledocholithiasis gallstones

As listed by the trial registrant

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

Common bile duct stone ERCP Robot surgery

Contacts and locations

Locations

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008, China

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