Trial Outcomes & Findings for Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge (NCT NCT01901562)
NCT ID: NCT01901562
Last Updated: 2023-11-09
Results Overview
Technical success will be determined by complete (total ductoscopic retrieval of a papilloma) ductoscopic retrieval of lesions over 90% of enrolled patients diagnosed with solitary papilloma.
TERMINATED
NA
9 participants
6 months
2023-11-09
Participant Flow
Participant milestones
| Measure |
Ductoscopic Papillectomy
Ductoscopic papillectomy to treat pathological nipple discharge
Ductoscopic papillectomy: Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Ductoscopic Papillectomy
Ductoscopic papillectomy to treat pathological nipple discharge
Ductoscopic papillectomy: Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy
|
|---|---|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Excluded intraoperatively
|
4
|
Baseline Characteristics
Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
Baseline characteristics by cohort
| Measure |
Ductoscopic Papillectomy
n=9 Participants
Ductoscopic papillectomy to treat pathological nipple discharge
Ductoscopic papillectomy: Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data related to the number of complete ductoscopic retrievals was not collected and analyzed.
Technical success will be determined by complete (total ductoscopic retrieval of a papilloma) ductoscopic retrieval of lesions over 90% of enrolled patients diagnosed with solitary papilloma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 weeks from the procedurePopulation: Data related to the number of participants with cessation of nipple discharge after ductoscopic papillectomy was not collected and analyzed.
Therapeutic success will be determined by cessation after ductoscopic papillectomy (DP) in over 95% of enrolled patients with pathologic nipple discharge (PND) with a single papilloma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data related to the recurrence of nipple discharge was not collected and analyzed.
Patients will be monitored for recurrence of nipple discharge at 6 month intervals for 2 years.
Outcome measures
Outcome data not reported
Adverse Events
Ductoscopic Papillectomy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sheldon Feldman, Chief Breast Surgery and Breast Surgery Oncology
Montefiore Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place