MedDataX Logo

Use of Human Dehydrated Amnion/Chorion (DHACM) Allograft in Partial Nephrectomy

NCT ID: NCT03323021

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-23

Study Completion Date

2019-02-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

After partial nephrectomy, kidney function decreases by about 10% overall and by about 20% in the operated kidney. This is primarily due to the loss of healthy parenchymal volume during resection of the tumor. In an effort to preserve and regenerate healthy parenchyma during the procedure and ultimately renal function after partial nephrectomy, the single center double arm single-blinded randomized screening clinical trial will evaluate the ability of human amnion/chorion allograft to facilitate the recovery of renal function following robotic partial nephrectomy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To determine whether Amniofix facilitates improved recovery of renal function at 12 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Partial Nephrectomy Kidney Cancer Renal Function Aggravated

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment with DHACM

Partial nephrectomy patched with DHACM

Group Type EXPERIMENTAL

Dehydrated human amnion/chorion membrane

Intervention Type OTHER

dehydrated human amnion/chorion membrane

Control without DHACM

Partial nephrectomy without DHACM.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Standard of Care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dehydrated human amnion/chorion membrane

dehydrated human amnion/chorion membrane

Intervention Type OTHER

Standard of Care

Standard of Care

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Any individual with a diagnosis of a renal mass.
* All Patients undergoing partial nephrectomy as their definitive treatment for their renal mass.
* Ability to understand and the willingness to sign a written informed consent.
* Patients with a solitary clinical T1a renal mass.

Exclusion Criteria

* Patients undergoing radical nephrectomy as their definitive treatment for their renal mass.
* Patients with Transitional Cell Carcinoma.
* Patients with known hereditary syndromes such Von Hippel-Lindau (VHL) syndrome, Lynch Syndrome, Birt-Hogg-Dube Syndrome.
* Patients with metastatic disease undergoing cytoreductive nephrectomy as their definitive treatment for metastatic disease.
* Patients with prior kidney surgery.
* Patients with a solitary or horseshoe kidney.
* Patients with a positive margin found during intra-operative frozen section done only when clinically indicated (i.e., macroscopic abnormality identified).
* Patients with multiple renal masses.
* Patients with greater than a clinical T1a renal mass.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

MiMedx Group, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ketan Badani, MD

Role: PRINCIPAL_INVESTIGATOR

Mt. Sinai Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Mount Sinai Hospital

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AFSUR001

Identifier Type: -

Identifier Source: org_study_id