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| ID | Type | Description | Link |
|---|---|---|---|
| U01NS083696 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, to produce an effective cough in patients with spinal cord injuries.
Patients with cervical spinal cord injuries often have paralysis of a major portion of their expiratory muscles - the muscles responsible for coughing - and therefore, lack a normal cough mechanism. Consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to the development of recurrent respiratory tract infections such as pneumonia and bronchitis. Expiratory muscles can be activated by electrical stimulation of the spinal roots to produce a functionally effective cough.
The purpose of this trial is to determine if electrical stimulation of the expiratory muscles by wire leads is capable of producing an effective cough on demand. According to the trial researchers, if successful, this technique will prevent the need for frequent patient suctioning - which often requires the constant presence of trained personnel. It will also allow spinal cord injured patients to clear their secretions more readily, thereby reducing the incidence of respiratory complications and associated illness and death.
In the trial, researchers will study 16 adults (18-75 years old) with cervical spinal injuries (C8 level or higher), at least 6 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have wire leads placed - by a routine, minimally invasive surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedure & Device | Experimental | Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expiratory muscle stimulator | Device | The expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough. | Peak Expiratory airflow rate is a person's maximum speed of expiration. Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration. It was measured after release of airway occlusion after peak airway pressure was achieved. | 52 weeks (1 year) |
| Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough | Maximum expiratory pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway. | 52 weeks (1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Secretion Management Episodes | This assessment allowed to characterize the severity of secretion management episodes and subjective assessment of the need for secretion management before and after use of the Cough System. Design: Prospective assessment via questionnaire responses Question: How significant were your needs for assistance with managing your airway secretions on a typical day during the past week? 0 None - Unaware of need
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony F. DiMarco, MD | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16543552 | Background | DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Spinal cord stimulation: a new method to produce an effective cough in patients with spinal cord injury. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1386-9. doi: 10.1164/rccm.200601-097CR. Epub 2006 Mar 16. | |
| 19406290 | Background | DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR, Frost FS, Creasey GH, Nemunaitis GA. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-Sponsored clinical trial. Part II: clinical outcomes. Arch Phys Med Rehabil. 2009 May;90(5):726-32. doi: 10.1016/j.apmr.2008.11.014. |
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Subjects were well informed of the details of the study, with particular interest to risks/benefits, and asked to review the Informed Consent before signing. They were given an opportunity to ask questions. Consent was obtained only after all questions and concerns have been addressed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Cord Stimulation With Wire Leads to Restore Cough | Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator Expiratory muscle stimulator: The expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box. Implantation of device: The expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle. The procedure to implant these wire leads is commonly used today for other purposes. This is a minimally invasive surgical technique with minimal risks. The wire leads are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box to stimulate the expiratory muscles and restore cough. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinical Trial: Spinal Cord Stimulation to Restore Cough | Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator Expiratory muscle stimulator: The expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box. Implantation of device: The expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle. The procedure to implant these wire leads is commonly used today for other purposes. This is a minimally invasive surgical technique with minimal risks. The wire leads are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box to stimulate the expiratory muscles and restore cough. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough. | Peak Expiratory airflow rate is a person's maximum speed of expiration. Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration. It was measured after release of airway occlusion after peak airway pressure was achieved. | Posted | Mean | Standard Error | L/s | 52 weeks (1 year) |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Post-Implantation; Spinal Cord Stimulation With Wire Leads to Restore Cough | Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator The expiratory muscle stimulator (Cough System) consists of two small electrodes (wire leads) implanted on the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box. Use of the spinal cord stimulation (SCS) Cough System was associated with some side effects, most notably increases in blood pressure and decreases in heart rate, consistent with autonomic dysreflexia (AD). AD was limited to the early phase of SCS and occurred in a total of 6 subjects. Over a period of several weeks of daily SCS however, this response gradually abated and eventually resolved in each subject. Mild back and leg jerking without associated discomfort was also observed in some subjects. This effect was well controlled by reducing the intensity of SCS. There was no evidence of bowel or bladder leakage. The Cough System have had to be explanted in one participant due increase in frequency and severity of muscle spasm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemodynamic effect - Initial increases in blood pressure and decreases in heart rate | Nervous system disorders | Systematic Assessment | Use of the Cough System was associated with some side effects (n=6), most notably increases in blood pressure, consistent with AD. Over a period of several weeks of daily SCS however, those responses were eventually resolved in each subject. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony F. DiMarco, MD | MetroHealth Medical Center | 216-778-3906 | afd3@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2015 | Nov 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2015 | Nov 22, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2022 | Jul 18, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013118 | Spinal Cord Diseases |
| D010243 | Paralysis |
| D002493 | Central Nervous System Diseases |
| D003371 | Cough |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| Implantation of device | Procedure | The expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle. The procedure to implant these wire leads is commonly used today for other purposes. This is a minimally invasive surgical technique with minimal risks. The wire leads are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box to stimulate the expiratory muscles and restore cough. |
|
| 52 weeks (1 year) |
| Difficulty Raising Sputum | Survey to assess difficulty raising sputum Objectives: To determine the difficulty raising sputum before and after use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: How much difficulty have you had with managing your airway secretions? On a scale of 0-4 (0 = None (No secretions), 1 = Mild (Rarely have difficulty), 2 = Moderate (Occasional difficulty) 3 = Marked (Frequent difficulty) and 4=Severe (Usually have great difficulty). | 52 weeks (1 year) |
| Number of Respiratory Tract Infections | Form covers frequency, type, severity, and antibiotic use for respiratory tract infections. The incidence of acute respiratory tract infections, defined by a change in the character, color, or amount of respiratory secretions and requiring antibiotic administration was tracked before and after implantation of the cough system. The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available. | 52 weeks (1 year) |
| Life Quality Assessment -Stress Level | Survey will assess the subject's quality of life at home and in social situations, as well as assess specific need for managing secretions. Objectives: Life Quality Assessment before and after use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: To what extent did managing your airway secretions cause you stress? On a scale of 0-3 (0 = Not at all, 1 = a little, 2 = Quite a bit and 3 = Very much) | 52 weeks (1 year) |
| 19406289 | Background | DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-sponsored clinical trial. Part I: methodology and effectiveness of expiratory muscle activation. Arch Phys Med Rehabil. 2009 May;90(5):717-25. doi: 10.1016/j.apmr.2008.11.013. |
| 22330116 | Background | Kowalski KE, DiMarco AF. Comparison of wire and disc leads to activate the expiratory muscles in dogs. J Spinal Cord Med. 2011 Nov;34(6):600-8. doi: 10.1179/2045772311Y.0000000039. |
| 7735601 | Background | DiMarco AF, Romaniuk JR, Supinski GS. Electrical activation of the expiratory muscles to restore cough. Am J Respir Crit Care Med. 1995 May;151(5):1466-71. doi: 10.1164/ajrccm.151.5.7735601. |
| 10368352 | Background | DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Pattern of expiratory muscle activation during lower thoracic spinal cord stimulation. J Appl Physiol (1985). 1999 Jun;86(6):1881-9. doi: 10.1152/jappl.1999.86.6.1881. |
| 10517775 | Background | DiMarco AF, Romaniuk JR, Kowalski KE, Supinski G. Mechanical contribution of expiratory muscles to pressure generation during spinal cord stimulation. J Appl Physiol (1985). 1999 Oct;87(4):1433-9. doi: 10.1152/jappl.1999.87.4.1433. |
| 1201534 | Background | Wada JA, Osawa T, Mizoguchi T. Recurrent spontaneous seizure state induced by prefrontal kindling in senegalese baboons, Papio papio. Can J Neurol Sci. 1975 Nov;2(4):477-92. doi: 10.1017/s031716710002062x. |
| 16959914 | Background | Romaniuk JR, Dick TE, Kowalski KE, Dimarco AF. Effects of pulse lung inflation on chest wall expiratory motor activity. J Appl Physiol (1985). 2007 Jan;102(1):485-91. doi: 10.1152/japplphysiol.00130.2006. Epub 2006 Sep 7. |
| 17158247 | Background | Kowalski KE, Romaniuk JR, DiMarco AF. Changes in expiratory muscle function following spinal cord section. J Appl Physiol (1985). 2007 Apr;102(4):1422-8. doi: 10.1152/japplphysiol.00870.2006. Epub 2006 Dec 7. |
| 17681870 | Background | DiMarco AF, Kowalski KE, Romaniuk JR. Effects of diaphragm activation on airway pressure generation during lower thoracic spinal cord stimulation. Respir Physiol Neurobiol. 2007 Oct 15;159(1):102-7. doi: 10.1016/j.resp.2007.06.007. Epub 2007 Jun 22. |
| 18403449 | Background | DiMarco AF, Kowalski KE. Effects of chronic electrical stimulation on paralyzed expiratory muscles. J Appl Physiol (1985). 2008 Jun;104(6):1634-40. doi: 10.1152/japplphysiol.01321.2007. Epub 2008 Apr 10. |
| 24090524 | Background | DiMarco AF, Kowalski KE, Hromyak DR, Geertman RT. Long-term follow-up of spinal cord stimulation to restore cough in subjects with spinal cord injury. J Spinal Cord Med. 2014 Jul;37(4):380-8. doi: 10.1179/2045772313Y.0000000152. Epub 2013 Nov 26. |
| 29339903 | Background | DiMarco AF, Geertman RT, Tabbaa K, Polito RR, Kowalski KE. Economic Consequences of an Implanted Neuroprosthesis in Subjects with Spinal Cord Injury for Restoration of an Effective Cough. Top Spinal Cord Inj Rehabil. 2017 Summer;23(3):271-278. doi: 10.1310/sci2303-271. |
| 29017400 | Background | DiMarco AF, Geertman RT, Tabbaa K, Polito RR, Kowalski KE. Case report: Minimally invasive method to activate the expiratory muscles to restore cough. J Spinal Cord Med. 2018 Sep;41(5):562-566. doi: 10.1080/10790268.2017.1357916. Epub 2017 Oct 11. |
| 30119089 | Background | DiMarco AF, Geertman RT, Tabbaa K, Kowalski KE. Complete Restoration of Respiratory Muscle Function in Three Subjects With Spinal Cord Injury: Pilot Interventional Clinical Trial. Am J Phys Med Rehabil. 2019 Jan;98(1):43-50. doi: 10.1097/PHM.0000000000001018. |
| Background | DiMarco AF, Geertman RT, Tabbaa K, Nemunaitis GA and Kowalski KE. Case Report: Effects of Lower Thoracic Spinal Cord Stimulation on Bowel Management in a Person with Spinal Cord Injury. Journal of Neurology and Neurobiology (2019) Volume 5 - Issue 1 | DOI: http://dx.doi.org/10.16966/2379-7150.156. |
| 31688014 | Background | DiMarco AF, Geertman RT, Tabbaa K, Kowalski KE. Complete Restoration of Respiratory Muscle Function in Subjects With Spinal Cord Injury: Interventional Clinical Trial. Am J Phys Med Rehabil. 2020 Jul;99(7):e91-e92. doi: 10.1097/PHM.0000000000001338. No abstract available. |
| 31809251 | Background | DiMarco AF, Geertman RT, Tabbaa K, Nemunaitis GA, Kowalski KE. Restoration of cough via spinal cord stimulation improves pulmonary function in tetraplegics. J Spinal Cord Med. 2020 Sep;43(5):579-585. doi: 10.1080/10790268.2019.1699678. Epub 2019 Dec 6. |
| 33161007 | Background | DiMarco AF, Geertman RT, Tabbaa K, Nemunaitis GA, Kowalski KE. Effects of Lower Thoracic Spinal Cord Stimulation on Bowel Management in Individuals With Spinal Cord Injury. Arch Phys Med Rehabil. 2021 Jun;102(6):1155-1164. doi: 10.1016/j.apmr.2020.09.394. Epub 2020 Nov 5. |
| 34232841 | Background | DiMarco AF, Geertman RT, Nemunaitis GA, Kowalski KE. Comparison of disc and wire electrodes to restore cough via lower thoracic spinal cord stimulation. J Spinal Cord Med. 2022 May;45(3):354-363. doi: 10.1080/10790268.2021.1936388. Epub 2021 Jul 7. |
| 37017634 | Derived | DiMarco AF, Geertman RT, Nemunaitis GA, Kowalski KE. Impact of the cough stimulation system on the care burden and life quality of caregivers of tetraplegics. J Spinal Cord Med. 2023 Sep;46(5):778-788. doi: 10.1080/10790268.2022.2148845. Epub 2023 Apr 5. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pre-Implant - Spontaneous Effort - Airway Pressure | A medical implant (cough system) has been removed (explanted ) from one participant due to increase in frequency and severity of spasms. | Mean | Standard Deviation | cmH2O |
|
| Participants |
|
|
|
| Primary | Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough | Maximum expiratory pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway. | Posted | Mean | Standard Error | cmH2O | 52 weeks (1 year) |
|
|
|
|
| Secondary | Secretion Management Episodes | This assessment allowed to characterize the severity of secretion management episodes and subjective assessment of the need for secretion management before and after use of the Cough System. Design: Prospective assessment via questionnaire responses Question: How significant were your needs for assistance with managing your airway secretions on a typical day during the past week? 0 None - Unaware of need
| Posted | Mean | Standard Error | score on a scale | 52 weeks (1 year) |
|
|
|
|
| Secondary | Difficulty Raising Sputum | Survey to assess difficulty raising sputum Objectives: To determine the difficulty raising sputum before and after use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: How much difficulty have you had with managing your airway secretions? On a scale of 0-4 (0 = None (No secretions), 1 = Mild (Rarely have difficulty), 2 = Moderate (Occasional difficulty) 3 = Marked (Frequent difficulty) and 4=Severe (Usually have great difficulty). | Posted | Mean | Standard Error | score on a scale | 52 weeks (1 year) |
|
|
|
|
| Secondary | Number of Respiratory Tract Infections | Form covers frequency, type, severity, and antibiotic use for respiratory tract infections. The incidence of acute respiratory tract infections, defined by a change in the character, color, or amount of respiratory secretions and requiring antibiotic administration was tracked before and after implantation of the cough system. The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available. | Posted | Mean | Standard Error | Respiratory tract infections per year | 52 weeks (1 year) |
|
|
|
|
| Secondary | Life Quality Assessment -Stress Level | Survey will assess the subject's quality of life at home and in social situations, as well as assess specific need for managing secretions. Objectives: Life Quality Assessment before and after use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: To what extent did managing your airway secretions cause you stress? On a scale of 0-3 (0 = Not at all, 1 = a little, 2 = Quite a bit and 3 = Very much) | Posted | Mean | Standard Error | score on a scale | 52 weeks (1 year) |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 6 |
| 12 |
|
| Muscle spasm | Nervous system disorders | Systematic Assessment | The Cough System have had to be explanted in one participant due an increase in frequency and severity of muscle spasm. |
|
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| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| Title | Measurements |
|---|---|
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| Post-Implantation Week #52 |
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| Title | Measurements |
|---|---|
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| Post-Implantation Week #52 |
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| Title | Measurements |
|---|---|
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| Post-Implantation Week #52 |
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| Title | Measurements |
|---|---|
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| Post-Implantation Week #52 |
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