Trial Outcomes & Findings for Plan A Novel Delivery Device Study (NCT NCT06891729)

NCT ID: NCT06891729

Last Updated: 2025-11-28

Results Overview

Treatment emergent adverse events

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 14 days post vasectomy procedure.
• Results posted on: 2025-11-28

Participant Flow

Epworth Healthcare (hospital facility, Australia): Recruitment period from March 20 - April 8, 2025. VasectoPro (Medical clinic, Canada): Recruitment period from May 9 - May 25, 2025.

All enrolled participants were included in the study.

Participant milestones

Measure	Interventional Arm All participants who provide informed consent and are deemed eligible will be treated with the investigational device immediately prior to their planned vasectomy. Delivery Lumen Access Device: Delivery Lumen Access Device use prior to Vasectomy DLAD: Participants will be exposed to the DLAD during their planned vasectomy
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Plan A Novel Delivery Device Study

Baseline characteristics by cohort

Measure	Interventional Arm n=24 Participants All participants who provide informed consent and are deemed eligible will be treated with the investigational device immediately prior to their planned vasectomy. Delivery Lumen Access Device: Delivery Lumen Access Device use prior to Vasectomy DLAD: Participants will be exposed to the DLAD during their planned vasectomy
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants
Age, Continuous	38.32 years STANDARD_DEVIATION 6.09 • n=30 Participants
Sex: Female, Male Female	0 Participants n=30 Participants
Sex: Female, Male Male	24 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants
Race (NIH/OMB) Asian	1 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants
Race (NIH/OMB) White	23 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants
Region of Enrollment Canada	20 participants n=30 Participants
Region of Enrollment Australia	4 participants n=30 Participants
Physical examination and vital signs.	24 Participants n=30 Participants

PRIMARY outcome

Timeframe: 14 days post vasectomy procedure.

Population: TEAES will captured during the procedure and through the 14 day follow up visit and study completion.

Treatment emergent adverse events

Outcome measures

Measure	Interventional Arm n=24 Participants All participants who provide informed consent and are deemed eligible will be treated with the investigational device immediately prior to their planned vasectomy. Delivery Lumen Access Device: Delivery Lumen Access Device use prior to Vasectomy DLAD: Participants will be exposed to the DLAD during their planned vasectomy
Adverse Events	10 Participants

Adverse Events

Interventional Arm

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Interventional Arm n=24 participants at risk All participants who provide informed consent and are deemed eligible will be treated with the investigational device immediately prior to their planned vasectomy. Delivery Lumen Access Device: Delivery Lumen Access Device use prior to Vasectomy DLAD: Participants will be exposed to the DLAD during their planned vasectomy
Reproductive system and breast disorders Scrotal Pain	16.7% 4/24 • Number of events 4 • Adverse events were captured from the first patients screening visit through the last patients Day 14 follow up visit. Adverse events were captured from the first patients screening visit through the last patients Day 14 follow up visit.
Reproductive system and breast disorders Non Infectious Inflammation	16.7% 4/24 • Number of events 4 • Adverse events were captured from the first patients screening visit through the last patients Day 14 follow up visit. Adverse events were captured from the first patients screening visit through the last patients Day 14 follow up visit.

Additional Information

Darlene Walley

Next Life Sciences

Phone: 415-407-5229

Email: darlene.walley@nextlifesciences.org

Results disclosure agreements

• Principal investigator is a sponsor employee The PI's may not publish or discuss the results without consent and review by NLS.
• Publication restrictions are in place

Restriction type: OTHER