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NCT01901562

Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge

Terminated NA Results posted Last updated 9 November 2023
What this trial tests

NA trial testing Ductoscopic papillectomy in Breast Discharge Infected in 9 participants. Terminated before completion.

Timeline
27 September 2013
Primary endpoint
11 January 2017
11 January 2017

Quick facts

Lead sponsorMontefiore Medical Center
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date27 September 2013
Primary completion11 January 2017
Estimated completion11 January 2017
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Montefiore Medical Center

Who can join

18 and older, female only, with Breast Discharge Infected or Intraductal Papilloma of Breast. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this prospective clinical trial, patients who sign an approved informed consent for ductoscopy to assess etiology of Pathologic nipple discharge (PND) will be enrolled in the study. Consented patients who have been diagnosed with a solitary papilloma within the discharging duct will be recruited to have interventional ductoscopy. Patients who are identified ductoscopically with a solitary non-sessile papilloma will undergo an attempted ductoscopic papillectomy (DP). Patients with ductoscopic findings other than single non-sessile papilloma will undergo standard ductoscopically guided microductectomy. The investigators will investigate whether the ductoscopic basket can be used as a safe endoscopic extraction instrument without adverse events. Histopathological evaluation will be performed to confirm the ductoscopic diagnosis and to determine the existence of any malignant tissue.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Montefiore Medical Center trials

Trials by the same sponsor.

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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/NCT01901562.

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