Fecal IncontinenceNCT03882632
Fat Grafting Technique for Fecal Incontinence
A study testing Fat Grafting for Fecal Incontinence in people with Fecal Incontinence, run by Melanie Salerno, RN at 1 site in United States.
Trial summary
Fecal Incontinence affects an estimated 2-20% of the general population, and up to 50% of the elderly and institutionalized population. Patients with incontinence tend to suffer in silence; they often do not seek help because of embarrassment and stigma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Fat Grafting for Fecal Incontinence
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to Dec 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: >18 < 65 years
- Sex: females
- Affected by fecal incontinence (moderate to severe) independently from the etiology and previous treatments
- No restrictions to follow-up for 24 months after treatment
- Willing and able to provide informed consent
Who cannot join
- Present diagnosis of cancer (not in remission)
- Patients with uncorrected rectal prolapse
- Overflow incontinence
- Patients with neurogenic bowel or spinal cord injuries
- Any patients unable to give informed consent, including members of vulnerable populations
- Patients with concomitant pelvic floor disorders, like paradoxical puborectalis contraction or pelvic floor dysfunction
Show all 13Show fewer
- Chronic diarrhea
- Patients with chronic steroid use
- Patients 17 and under
- Anal Sepsis (abscess and/or fistula)
- Inability to undergo the intended diagnostic tests and follow-up
- Pregnancy
- Diagnosis of Diabetes Mellitus 1 and 2
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lifespan
Providence, Rhode Island, 02903
Melanie Salerno, RN, 401-444-7148, melanie.salerno@brownphysicians.org
Leslie Roth, MD
About this study
Official title: Evaluation of Fat Grafting Technique Using Autologous Micro-fragmented Autologous Adipose Tissue Lipogems in Fecal Incontinence
Fecal Incontinence affects an estimated 2-20% of the general population, and up to 50% of the elderly and institutionalized population. Patients with incontinence tend to suffer in silence; they often do not seek help because of embarrassment and stigma. They often become confined to their homes because they are afraid of having an "accident". Although this is not a life-threatening condition, the psychological, emotional, and social impact can be devastating.
Read the detailed description
The purpose of this study is to evaluate reconstructive lipoplasty with micro-fragmented autologous adipose tissue (Lipogems®) in female patients with fecal incontinence. Our hypothesis is that placing approximately up to 90 cc of Lipogems® will yield an effective increase in surviving material (over normal fat injection) due to the refinement of the process and result in decreased fecal incontinence over the long term.
Human Adipose Tissue (Fat) possesses regenerative properties in its stromal vascular fraction (SVF). SVF contains nests of pericytes and human MSC mesenchymal stem cells). MSCs are multipotent cells (also called stromal multipotent cells), that possess the ability to differentiate into various tissues, such as bone, tendon, articular cartilage, ligaments, muscle, and fat. Upon fragmentation of adipose tissue using Lipogems®, viable elements are preserved with pericyte identity within an intact stromal vascular niche. It is hypothesized that upon trauma or disruption of this adipose tissue, the regenerative cells within the intact perivascular niche interact via micro vesicles with the microenvironment at the transplant site to promote angiogenesis, neuronal sprouting and fibroblast production thereby stimulating increased vasculature (circulation, nerve regeneration, muscle growth and tone in the urethral sphincter and in the urethral muscles). If these changes are observed, long lasting regenerative changes occur and should be long lasting versus the shorter live effects of the bulking effect by undisrupted fat tissue.
This is a pilot study of 10 subjects will be treated with local injections of Lipogems® and followed for up to two years. Subjects will receive a full history and examination by a single colorectal surgeon. A clear history of their incontinence frequency, Wexner Incontinence Score, Fecal Incontinence Quality of Life Scale, surgical history, and childbirth history will be collected for all registered patients in order to categorize the study participant according to incontinence-type.
All patients will undergo anal physiology testing and endoanal ultrasound. Pre and post measurements will be recorded and compared for objective evaluation. Patients will be evaluated subjectively with the Wexner incontinence Score and Fecal Incontinence Quality of Life Scale.
Patients will have the opportunity to undergo adipose tissue harvesting and targeted local Injection under ultrasound guidance in muscle defects in the intersphincteric space, all around the remaining portions of the external anal sphincter, and along the course of the pudendal nerves bilaterally. This will be done in the procedure room or operating room with IV sedation and local anesthesia. This will all occur in the same setting on the same day.
- Conditions
- Fecal Incontinence
- Being tested
- Fat Grafting for Fecal Incontinence
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat Grafting for Fecal IncontinenceDevice
Also called Fat Grafting
Autologous adiopse tissue harvesting/grafting using Lipogems
| Study group | Role | What they receive |
|---|---|---|
| Patients with Fecal Incontinence | Experimental | Patients will have the opportunity to undergo adipose tissue harvesting and targeted local Injection under ultrasound guidance in muscle defects in the intersphincteric space, all around the remaining portions of the external anal sphincter, and along the course of the pudendal nerves bilaterally Receives: Device: Fat Grafting for Fecal Incontinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Fecal Incontinence Measured by patient reported outcomes on questionnaires
Comparison of pre and post procedure outcomes via outcomes questionaires
Measured: 2 years
Resolution of Fecal Incontinence Measured by Physical Exam
Comparison of pre and post procedure outcomes via Endoanal Ultrasound and Physiology Testing
Measured: 2 years
Secondary outcomes (1)
Incident of treatment related adverse events
Site reported adverse events designated as related to treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start11 Apr 2019
- Primary completionApr 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melanie Salerno, RN
- Sponsor type
- University, hospital or other
- Collaborators
- Lifespan
- Responsible party
- Sponsor-investigator, Melanie Salerno, RN, Brown Physicians, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882632
- Sponsor's protocol ID
- 1125611
- Status last verified
- Jul 2020
- First submitted
- 18 Mar 2019
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fat Grafting Technique Using Autologous Micro-fragmented Autologous Adipose Tissue Lipogems in Fecal Incontinence
- ClinicalTrials.gov ID
- NCT03882632
- Acronym / sponsor ID
- 1125611
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Melanie Salerno, RNUniversity, hospital or other
- Collaborators
- Lifespan
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Mar 2019 (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.
Fecal Incontinence affects an estimated 2-20% of the general population, and up to 50% of the elderly and institutionalized population. Patients with incontinence tend to suffer in silence; they often do not seek help because of embarrassment and stigma. They often become confined to their homes because they are afraid of having an "accident". Although this is not a life-threatening condition, the psychological, emotional, and social impact can be devastating.
Detailed description
The purpose of this study is to evaluate reconstructive lipoplasty with micro-fragmented autologous adipose tissue (Lipogems®) in female patients with fecal incontinence. Our hypothesis is that placing approximately up to 90 cc of Lipogems® will yield an effective increase in surviving material (over normal fat injection) due to the refinement of the process and result in decreased fecal incontinence over the long term.
Human Adipose Tissue (Fat) possesses regenerative properties in its stromal vascular fraction (SVF). SVF contains nests of pericytes and human MSC mesenchymal stem cells). MSCs are multipotent cells (also called stromal multipotent cells), that possess the ability to differentiate into various tissues, such as bone, tendon, articular cartilage, ligaments, muscle, and fat. Upon fragmentation of adipose tissue using Lipogems®, viable elements are preserved with pericyte identity within an intact stromal vascular niche. It is hypothesized that upon trauma or disruption of this adipose tissue, the regenerative cells within the intact perivascular niche interact via micro vesicles with the microenvironment at the transplant site to promote angiogenesis, neuronal sprouting and fibroblast production thereby stimulating increased vasculature (circulation, nerve regeneration, muscle growth and tone in the urethral sphincter and in the urethral muscles). If these changes are observed, long lasting regenerative changes occur and should be long lasting versus the shorter live effects of the bulking effect by undisrupted fat tissue.
This is a pilot study of 10 subjects will be treated with local injections of Lipogems® and followed for up to two years. Subjects will receive a full history and examination by a single colorectal surgeon. A clear history of their incontinence frequency, Wexner Incontinence Score, Fecal Incontinence Quality of Life Scale, surgical history, and childbirth history will be collected for all registered patients in order to categorize the study participant according to incontinence-type.
All patients will undergo anal physiology testing and endoanal ultrasound. Pre and post measurements will be recorded and compared for objective evaluation. Patients will be evaluated subjectively with the Wexner incontinence Score and Fecal Incontinence Quality of Life Scale.
Patients will have the opportunity to undergo adipose tissue harvesting and targeted local Injection under ultrasound guidance in muscle defects in the intersphincteric space, all around the remaining portions of the external anal sphincter, and along the course of the pudendal nerves bilaterally. This will be done in the procedure room or operating room with IV sedation and local anesthesia. This will all occur in the same setting on the same day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Fecal Incontinence | Experimental | Device: Fat Grafting for Fecal IncontinencePatients will have the opportunity to undergo adipose tissue harvesting and targeted local Injection under ultrasound guidance in muscle defects in the intersphincteric space, all around the remaining portions of the external anal sphincter, and along the course of the pudendal nerves bilaterally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: >18 < 65 years
- Sex: females
- Affected by fecal incontinence (moderate to severe) independently from the etiology and previous treatments
- No restrictions to follow-up for 24 months after treatment
- Willing and able to provide informed consent
Key exclusion criteria (13 listed)
- Present diagnosis of cancer (not in remission)
- Patients with uncorrected rectal prolapse
- Overflow incontinence
- Patients with neurogenic bowel or spinal cord injuries
- Any patients unable to give informed consent, including members of vulnerable populations
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 |
|---|---|---|
| Fat Grafting for Fecal IncontinenceAlso: Fat GraftingAutologous adiopse tissue harvesting/grafting using Lipogems | Device | Patients with Fecal Incontinence |
Primary outcome
Resolution of Fecal Incontinence Measured by patient reported outcomes on questionnaires
Time frame: 2 years
Comparison of pre and post procedure outcomes via outcomes questionaires
Resolution of Fecal Incontinence Measured by Physical Exam
Time frame: 2 years
Comparison of pre and post procedure outcomes via Endoanal Ultrasound and Physiology Testing
1 secondary outcome
Incident of treatment related adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat Grafting for Fecal Incontinence in people with Fecal Incontinence, run by Melanie Salerno, RN 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 9 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie Salerno (4014447148, melanie.salerno@brownphysicians.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of Fecal Incontinence Measured by patient reported outcomes on questionnaires (time frame: 2 years). The study lists 2 primary outcomes in all. 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 9 Jul 2020.