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NCT04231812

First In Human Study Evaluating the Safety and Performance of the "LapBox" Containment System for Laparoscopic Tissue Morcellation

Status unknown NA Last updated 18 January 2020
What this trial tests

NA trial testing Laparoscopic Tissue Morcellation working space (bag) in Laparoscopic Surgical Procedure in 10 participants. Status unknown.

Timeline
25 January 2020
Primary endpoint
1 May 2020
1 May 2020

Quick facts

Lead sponsorARKSurgical
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposedevice feasibility
Enrollment10
Start date25 January 2020
Primary completion1 May 2020
Estimated completion1 May 2020

Drugs / interventions tested

Conditions studied

Sponsor

ARKSurgical

Who can join

Adults 18 to 50, female only, with Laparoscopic Surgical Procedure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study to assess the safety, and performance of the LapBox in patients in terms of duration of deployment, organ insertion into the "LapBox" bag, ease of use, success of containment and performance.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04231812.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing