ClinicalTrials.gg
CompletedNCT03323021Updated Nov 13, 2020

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

An interventional study of Dehydrated human amnion/chorion membrane and Standard of Care in Partial Nephrectomy, Kidney Cancer and Renal Function Aggravated, sponsored by MiMedx Group, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by MiMedx Group, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled May 2017, registered Oct 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 551 studies in Kidney Neoplasms with a site in United States — 67 open to participants now, 109 under way, 4 of them phase 3. Kidney Neoplasms · United States.

Enrollment
148th of 443
61 · median 37
Started
2017
with 25 others
No phase
58 of 551
10 open now
Registered
415th of 551
by date

Among the 551 studies in Kidney Neoplasms with a site in United States, this one is the 148th largest by enrollment of the 443 interventional ones that give a count, is one of 26 that started in 2017, is one of 58 with no phase, and was the 415th registered.

Kidney Neoplasms

969 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

Browse Kidney Neoplasms studies →

Open to participants now

67 of the 551 studies in Kidney Neoplasms with a site in United States are open now. Recruiting first, the newest first:

62 more — sign in →

All 67 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 173 Kidney Neoplasms studies recruiting now, 133 (77%) set no upper age limit and 15 (9%) stop at 75 or younger; 20 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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.

Read the detailed description

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

03

Conditions studied

  • Partial Nephrectomy
  • Kidney Cancer
  • Renal Function Aggravated

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • Patients with a solitary clinical T1a renal mass.

Exclusion criteria

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Treatment with DHACM

    Partial nephrectomy patched with DHACM

    Other: Dehydrated human amnion/chorion membrane

  • Active comparator
    Control without DHACM

    Partial nephrectomy without DHACM.

    Other: Standard of Care

Interventions

  • OtherDehydrated human amnion/chorion membrane

    dehydrated human amnion/chorion membrane

  • OtherStandard of Care

    Standard of Care

06

What researchers measure

Primary outcomes

  1. Recovery of Renal Function

    Evaluation of GlomerularFiltration Rate (GFR)

    Time frame: 12 months

Secondary outcomes

  1. Preservation of Renal Parenchymal Volume

    Using radiologic computed tomography measurements

    Time frame: 12 months

  2. Cancer Control Rates

    Observed recurrence rate

    Time frame: 12 months

07

Study locations

1 site
  • The Mount Sinai Hospital
    New York, New York 10029, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2017 to primary completion in Feb 2019, 20 months.

Of 97 interventional studies with no phase under Kidney Neoplasms, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 90. This study's 20 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2017
First posted
Oct 26, 2017
StartActual
May 23, 2017
Primary completionActual
Feb 21, 2019
CompletionActual
Feb 21, 2019
Last update
Nov 13, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03323021
Lead sponsor
MiMedx Group, Inc.
Responsible party
Sponsor
First posted
Oct 26, 2017
Start date
May 23, 2017
Primary completion
Feb 21, 2019
Completion
Feb 21, 2019
Last update
Nov 13, 2020

Study contacts

Ketan Badani, MD
principal investigator · Mt. Sinai Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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