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NCT03402516: DIAPER

Comparison of Two Bipolar Resector in Less Than 3cm Myoma Resection

Status unknown NA Last updated 27 January 2021
What this trial tests

NA trial testing 18.5 resector in Rate of Complete Resection in a Unique Surgical Time in 308 participants. Status unknown.

Timeline
1 November 2017
Primary endpoint
31 December 2021
31 March 2022

Quick facts

Lead sponsorBicetre Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment308
Start date1 November 2017
Primary completion31 December 2021
Estimated completion31 March 2022
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Bicetre Hospital

Who can join

18 and older, female only, with Rate of Complete Resection in a Unique Surgical Time. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hysteroscopic resection of type 0, 1 or 2 myoma is frequent. The more frequent resector used for myoma resection is 26Fr hysteroscope. Actual miniaturization of resector led to 18.5Fr resector with a potential benefit because of less dilatation. These resectors are often used but no scientific evaluation has been performed. Hypothesis of this non inferiority trial is that complete resection in a unique surgical time will be comparable with both resectors.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Bicetre Hospital trials

Trials by the same sponsor.

Verify against primary sources

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/NCT03402516.

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