Partial NephrectomyNCT03323021
Use of Human Dehydrated Amnion/Chorion (DHACM) Allograft in Partial Nephrectomy
A study testing Dehydrated human amnion/chorion membrane in people with Partial Nephrectomy and Kidney Cancer, run by MiMedx Group, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Nephrectomy, Kidney Cancer, Renal Function Aggravated
- What is being tested?
- Dehydrated human amnion/chorion membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 21 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center Double Arm Single-Blinded Randomized Screening Clinical Trial to Evaluate the Use of Human Dehydrated Amnion/Chorion Membrane to Facilitate the Recovery of Renal Function Following Robotic Partial Nephrectomy
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.
- Being tested
- Dehydrated human amnion/chorion membrane, Standard of Care
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydrated human amnion/chorion membraneOther
dehydrated human amnion/chorion membrane
Standard of CareOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Treatment with DHACM | Experimental | Partial nephrectomy patched with DHACM Receives: Other: Dehydrated human amnion/chorion membrane |
| Control without DHACM | Active comparator | Partial nephrectomy without DHACM. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of Renal Function
Evaluation of GlomerularFiltration Rate (GFR)
Measured: 12 months
Secondary outcomes (2)
Preservation of Renal Parenchymal Volume
Using radiologic computed tomography measurements
Measured: 12 months
Cancer Control Rates
Observed recurrence rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start23 May 2017
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial NephrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ketan Badani, MD, Principal investigator, Mt. Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323021
- Sponsor's protocol ID
- AFSUR001
- Status last verified
- Nov 2020
- First submitted
- 24 Oct 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Double Arm Single-Blinded Randomized Screening Clinical Trial to Evaluate the Use of Human Dehydrated Amnion/Chorion Membrane to Facilitate the Recovery of Renal Function Following Robotic Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT03323021
- Acronym / sponsor ID
- AFSUR001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2017 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
To determine whether Amniofix facilitates improved recovery of renal function at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with DHACM | Experimental | Other: Dehydrated human amnion/chorion membranePartial nephrectomy patched with DHACM |
| Control without DHACM | Active comparator | Other: Standard of CarePartial nephrectomy without DHACM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dehydrated human amnion/chorion membranedehydrated human amnion/chorion membrane | Other | Treatment with DHACM |
| Standard of CareStandard of Care | Other | Control without DHACM |
Primary outcome
Recovery of Renal Function
Time frame: 12 months
Evaluation of GlomerularFiltration Rate (GFR)
2 secondary outcomes
Preservation of Renal Parenchymal Volume
Time frame: 12 months
Cancer Control Rates
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
Related trials for Partial Nephrectomy
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
RecruitingObservational study
Mapping Recovery, Quality of Life, and Physical Function After Partial and Radical Nephrectomy
Nephrectomy / Methods, Nephrectomy
Active, not recruitingPhase 2
NSAID Use After Robotic Partial Nephrectomy
Kidney Cancer, Renal Cancer
Recruiting
Effect of Non-Clamping and Sutureless Technique on Postoperative Renal Function in Robot-Assisted Partial Nephrectomy
Renal Neoplasms, Localized Kidney Tumors
RecruitingPhase 2
Perioperative Ursodeoxycholic Acid for Renal Protection in Adults Undergoing Partial Nephrectomy for Renal Tumors
Kidney Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ketan Badani, MD principal investigator
Mt. Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dehydrated human amnion/chorion membrane in people with Partial Nephrectomy and Kidney Cancer, run by MiMedx Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of Renal Function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.