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Experimental device trial launches – details under wraps

NCT ID NCT06217081

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Updated 2 times

Summary

This clinical trial is testing a device that has not been approved or cleared by the U.S. FDA. The purpose is to learn more about how the device works and its effects on participants. Because key details are not publicly available, the exact goals and methods are unclear.

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

78 people

The number who actually took part.

Started

Oct 2024

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

22 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: * Subject is at least 22 years of age on the date of informed consent * Subject or Subject's legally authorized representative can provide informed consent * Subject is willing and able to attend all scheduled study visits and abide by all study restrictions * Subject has a single laceration that is ≤ 100 mm (10.0 cm) in length or up to 4 surgical incision(s), each ≤ 100 mm (10.0 cm) in length, defined as Class I or Class II wound(s), in which the use of a tissue adhesive (in combination with but not replacing deep dermal sutures, if applicable) is appropriate, including the following: * surgical incision from a minimally invasive surgery * low tension incision * superficial laceration * clean, traumatic laceration with edges that can be easily approximated Exclusion Criteria: * Subject has a positive pregnancy test within 48 hours prior to randomization at Day 0 or is lactating prior to randomization at Day 0 * Subject is found to have any of the following before randomization: * a known peripheral vascular disease * a history of hypertrophic scarring and/or keloids * any Class III or Class IV wounds * uncontrolled diabetes mellitus (DM), defined as HbA1C ≥ 10% within 90 days before screening. If HbA1C data is unavailable or the Subject presents in an emergency situation, uncontrolled DM will be defined as blood glucose ≥ 250 mg/dL * a known blood clotting disorder * immunocompromised * a known systemic or local bacterial, viral, or fungal infection * critical injury * condition(s) that in the opinion of the Investigator will impact study results (eg, hemophilia or autoimmune disorder) or the ability of the Subject to remain compliant with study procedures, study restrictions, and/or visits * Subject has a known hypersensitivity or allergy to any of the components of study products (eg, polyoxamides or cyanoacrylates) * Subject is concurrently participating in or was enrolled in another interventional clinical study within 30 days of randomization * Subject has a laceration or incision that is \> 100 mm (10 cm) in length * Subject has any incision that is within 5 cm of any adjacent incision * Subject has one of the following: * a "burst" or stellate laceration * wound with exposed bone * wound with suspected skin edge ischemia due to extensive undermining * wound requiring drain(s) * wound requiring a conventional closure method (eg, subcuticular/intradermal suture, staples, adhesive strips) OR subcuticular stitch placement for enhanced wound support (ie, to further minimize tension) * Subject has a wound with any of the following etiologies: * human or animal bite * prolonged pressure (ie, decubitus) * Subject has a wound in any of the following anatomical locations: * on mucosal surfaces or across mucocutaneous junctions (eg, oral cavity, lips) * in or around the eyes * an anatomical area that is under tension or over a joint * on an area that may be regularly exposed to body fluids or with dense natural hair present (eg, scalp)

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Conditions

The condition(s) this trial relates to.

injury Lacerations Surgical Wound

As listed by the trial registrant

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

More trials for these conditions

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