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New device aims to seal pancreas during robotic surgery, cutting leak risk

NCT ID NCT07687901

Disease control Sponsor: Hospital del Mar Source: ClinicalTrials.gov ↗

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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.
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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 Results may not be published yet.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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This pilot study tests a new device that uses radiofrequency energy to seal the pancreas during robotic surgery to remove the tail of the pancreas. The device, called Attachable Coolingbis®, is designed to reduce the common complication of pancreatic fluid leaks. Twenty adults with pancreatic tumors will undergo the procedure at four Spanish hospitals, and researchers will monitor safety and complication rates for up to one year.

What this could mean

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

Active substance
Internally-cooled bipolar radiofrequency device (Attachable Coolingbis®)
What this could lead to
If successful, this device could reduce the high rate of pancreatic leaks after distal pancreatectomy, making robotic surgery safer for patients with pancreatic tumors.
What could go wrong
This is a small, early-stage pilot study with only 20 participants and no comparison group. The device may not reduce complications as hoped, and risks include bleeding, infection, or fistula formation.

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.

Participants

About 20 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

Aug 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.

Who is studied

Consecutive cohort of adult patients with a clinical indication for distal pancreatectomy due to solid or cystic pancreatic neoplasms (benign, premalignant, or malignant), recruited from the surgical waiting lists of four Spanish hepatobiliopancreatic referral centers (Hospital del Mar, Barcelona; Hospital Universitario HM Sanchinarro, Madrid; Hospital Clínico Universitario de Valencia; Hospital Universitario Virgen del Rocío, Sevilla). Approximately 5 patients per center are expected to be enrolled, based on each center's estimated annual surgical volume for this indication (5-7 cases/year). All participants will be drawn from patients who are surgical candidates for robotic distal pancreatectomy and who meet the anatomical requirement of a planned transection line located more than 2 cm to the left of the medial border of the superior mesenteric vein.

Ages

18 years and older

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: * Age 18 years or older * Diagnosis of solid or cystic pancreatic neoplasm (benign, premalignant, or malignant) with surgical indication * Requirement for distal pancreatectomy with a planned transection line located more than 2 cm to the left of the medial border of the superior mesenteric vein (SMV), confirmed by CT or MRI performed within 2 months prior to surgery * Eligible for either splenic-preserving distal pancreatectomy or distal splenopancreatectomy * Eligible for open or minimally invasive surgical approach (laparoscopic or robotic) * Able to provide written informed consent Exclusion Criteria: * ASA (American Society of Anesthesiologists) physical status classification greater than 3 * Legal or cognitive incapacity to sign informed consent * Confirmed or ongoing pregnancy * Need for emergency surgery (e.g., post-traumatic pathology or acute complications)

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Conditions

The condition(s) this trial relates to.

pancreatic neoplasm

As listed by the trial registrant

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

Pancreatectomy

How to take part

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  1. The official record

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