dMD-002 Pilot Study in Patients With Cavernous Nerve Inju... | NCT07564102

Studies
dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy

NCT07564102

Sponsor

Mochida Medical USA, Inc.

Status

Not yet recruiting

Last Update Posted

May 15, 2026Actual

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Prostate Cancer

Interventions

dMD-002
Control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Sep 30, 2027Estimated

Completion Date

Jun 30, 2028Estimated

First Submitted Date

Apr 26, 2026

First Submission Date that Met QC Criteria

Apr 26, 2026

First Posted Date

May 4, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2026

Last Update Posted Date

May 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to conduct a US Pilot study of dMD-002 as a peripheral nerve repair sheet in patients with cavernous nerve injury following radical prostatectomy. The study will determine which endpoints and timepoints will be used for the pivotal study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental		Device: dMD-002
Control group	Sham Comparator		Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dMD-002	Device	The cut dMD-002 is implanted to cover the nerve injury, tear, or defect, and is fixed by suturing to the surrounding tissue in two or more places.	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean IIEF-EF scores		6 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Mean EHS score		Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months
Mean SHIM score		Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with prostate cancer.
Patients scheduled to undergo a robot-assisted radical prostatectomy (including either bilateral-nerve sparing or unilateral-nerve sparing) for treatment of prostate cancer.

etc.

Exclusion Criteria:

Patients undergoing pre-surgery or post-surgery radiation therapy, hormone therapy, or anti-cancer therapy.
Patients who have used a penile prosthesis implantation.
Patients with a history of transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, cryoablation, or other prostate surgery.

etc.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nozomu Watanabe	Contact	901-666-1308		dmd00203@mochida-medical.com
Mochida Public Relations	Contact			webmaster@mochida.co.jp

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Icahn School of Medicine at Mount Sinai		New York	New York	10029	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided