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NCT05755139 · ClinicalTrials.gov registry record · NA

Safety and Efficacy Evaluation of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL

A NA study, sponsored by Lumenis Be.

Completed
Registry status
NA
Development phase
60
Enrollment target

NCT05755139: Completed NA study, sponsored by Lumenis Be.

NCT05755139 is a NA study that has completed, run by Lumenis Be. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05755139, a NA study, has completed, sponsored by Lumenis Be.

COMPLETED
Registry status
NA
Development phase
60 participants
Enrollment target

Study Summary

Multi-center, Prospective, Open-Label with Before-After Study Design. Each subject will receive a single treatment. Treatment presets will be determined by the SMART Camera system and approved by the physician. Follow-up will take place at 1 month following the treatment. Skin and lesion attributes will be examined by the SMART system and the physician

Primary Outcome

Treatment with the SMART IPL system will be considered safe when a full treatment is completed using the recommended presets by the AI system (presets are not overruled due to safety by the physician) with no serious AEs. The overall percentage of safe treatments using the AI-recommended presets from all treatments will be calculated through study completion, an average of 3 months.

Interventions

  • DEVICE IPL with smart diagnostic handpiece

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2022-12-04
Est. Completion 2023-08-15
Phase NA
Lumenis Be

20 total trials

What the finished NCT05755139 record still lists

NCT05755139 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which IPL with smart diagnostic handpiece is the first listed.

NCT05755139 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05755139 about?

NCT05755139 is a clinical study titled "Safety and Efficacy Evaluation of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL". Multi-center, Prospective, Open-Label with Before-After Study Design. Each subject will receive a single treatment. Treatment presets will be determined by the SMART Camera system and approved by the physician. Follow-up will take place at 1 month following the treatment. Skin and lesion attributes ...

What is the current status of trial NCT05755139?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2022-12-04. Estimated completion is 2023-08-15.

What interventions are being tested in trial NCT05755139?

The interventions under investigation include: IPL with smart diagnostic handpiece (DEVICE).

Who is sponsoring clinical trial NCT05755139?

This trial is sponsored by Lumenis Be, which has 20 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05755139's enrollment target sits among peer trials

60 1164th of 2000 higher than 745 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05755139, the US trial registry maintained by the National Library of Medicine. NCT05755139 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.