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NCT01901562
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
NA trial testing Ductoscopic papillectomy in Breast Discharge Infected in 9 participants. Terminated before completion.
11 January 2017
Quick facts
| Lead sponsor | Montefiore Medical Center |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 27 September 2013 |
| Primary completion | 11 January 2017 |
| Estimated completion | 11 January 2017 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Ductoscopic papillectomy
Conditions studied
- Breast Discharge Infected — all drugs for Breast Discharge Infected →
- Intraductal Papilloma of Breast — all drugs for Intraductal Papilloma of Breast →
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.
Verify or expand the search:
- PubMed search for NCT01901562
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01901562 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Montefiore Medical Center
- Last refreshed: 9 November 2023
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing